Condition category
Cancer
Date applied
10/12/2018
Date assigned
21/01/2019
Last edited
21/01/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The NOSTRA-Feasibility Study will help us to find out if cancer that is still present after treatment with chemotherapy, trastuzumab and pertuzumab can be detected in biopsies taken from the site of a cancer. We are asking patients if they are willing to have ultrasound guided tumour bed core biopsies of their breast after finishing chemotherapy and before having surgery.

Many patients are now recommended to have drug treatment before surgery. After drug treatment we operate on the breast to remove any remaining cancer. Sometimes the drugs have killed all the cancer cells in the breast and there is no cancer in the breast tissue, we call this a pathological Complete Response (pCR). Patients with a pCR are at much lower risk of disease recurrence than those where cancer is still detected at surgery. At present, patients with early invasive breast cancer, will always have surgery after chemotherapy treatment. This is partly because that is what has always been done and partly because research has not been done before to see if it is possible to tell who has a pCR and who has residual cancer and requires surgery. The information from this feasibility study will be used to help us design a large clinical trial to find out if surgery could be avoided in patients who have achieved a pCR. Radiotherapy is currently used after surgery to treat any microscopic cancer that remains in the breast. In future it may be used in combination with chemotherapy without the need for surgery. This is an important study which may lead to change in the way breast cancer is treated, saving women from potentially unnecessary surgery.

We want to learn as much as possible about early stage invasive breast cancer and will be collecting tumour samples and blood samples as part of the NOSTRA-Feasibility Study. This will allow scientists to study the tumour sample and blood samples so that they can learn more about the natural history of early stage invasive breast cancer and try to understand how the cancer cells work and to study the effects of the drugs used in the study. With tumour samples in particular, we will try to identify ‘markers’ that may predict which treatments will work for which patients. The collection of blood is optional and we will use the blood samples to understand why a cancer develops and also look at how DNA in the cancer is changed.

Who can participate?
Patients with HER2-positive, oestrogen receptor (ER) negative, early stage invasive breast cancer.

What does the study involve?
Patients will receive one of the three NICE approved neoadjuvant chemotherapy regimens, plus dual-targeted anti-HER2 treatment with pertuzumab and trastuzumab at the discretion of the treating clinician.

What are the possible benefits and risks of participating?
We consider this to be a low risk study. The chemotherapy regimens employed in this study are widely used as standard care in the UK. Sites will be familiar with managing the toxicity associated with these drugs as safety profiles of the chemotherapy are well characterised. The surgical and SLNB procedure is also a standard technique. Thus the experience of patients taking part in the study will be very similar to those who are treated in accordance with standard care. The most significant difference for patients taking part in the study is the collection of the protocol defined tumour bed core biopsies.

Chemotherapy has several side effects that are well recognised. A common side effect from all chemotherapy drugs is a risk of infections and fever due to low white blood cells caused by chemotherapy. Diarrhoea, nausea, constipation, anaemia and loss of appetite are also common. Other common side effects are bruising and bleeding, fatigue, sore mouth and mouth ulcers dry skin and heart damage. Epirubicin can cause heart damage, because of this it is not given to patients with serious heart conditions and the amount of this drug you can have in your lifetime is restricted. Cyclophosphamide and epirubicin cause a very small increase in risk of leukaemia in later life but this is rare. Docetaxel can cause nerve damage experienced as numbness and tingling in feet and hands. It can cause joint aches and muscle pains.

Trastuzumab can cause temporary flu like symptoms such as shivering and a temperature after the first few administrations and can cause heart problems which can cause shortness of breath.

There is increasing evidence that patients who have their treatment as part of a clinical trial may have better outcomes than those who do not. It is intended that as a result of this study, doctors will know if taking biopsies from the breast after treatment is a reliable way of knowing if there is any cancer left. The information obtained from this study will also change and improve the way breast cancer is treated in the future and may be able to avoid unnecessary breast surgery as a direct result of the knowledge gained from this study. Also the data, tumour and blood samples collected may give us a better understanding of cancer genes and DNA, and what other processes are involved in causing breast cancer and in understanding how current treatments work. This may then be used to develop a better understanding for the treatment of breast cancer in future.

Where is the study run from?
NOSTRA-Feasibility Study Office
Cancer Research UK Clinical Trials Unit
Institute of Cancer and Genomic Sciences
University of Birmingham
Vincent Drive
Edgbaston
Birmingham
B15 2TT

When is the study starting and how long is it expected to run for?
January 2019 to June 2020

Who is funding the study?
It is funded by Roche. Endorsed by Cancer Research UK, Clinical Trials Advisory & Awards Committee (CTAAC).

Who is the main contact?
Miss Dalbir Kaur
D.Kaur@bham.ac.uk

Trial website

http://www.birmingham.ac.uk/crctu

Contact information

Type

Scientific

Primary contact

Miss Dalbir Kaur

ORCID ID

Contact details

NOSTRA-Feasibility Study Trial Coordinator
Cancer Research UK Clinical Trials Unit
Institute of Cancer and Genomic Sciences
University of Birmingham
Vincent Drive
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38071

Study information

Scientific title

A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound-guided tumour bed core biopsies

Acronym

NOSTRA-Feasibility Study

Study hypothesis

The NOSTRA-Feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment. The study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.

Ethics approval

West Midlands- Solihull Research Ethics Committee, 12/11/2018, ref. 18/WM/0257.

Study design

Non-randomised; Observational; Design type: Validation of investigation /therapeutic procedures

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Cancer, Primary sub-specialty: Breast Cancer; Health Category: Cancer and neoplasms; Disease/Condition: Malignant neoplasm of breast

Intervention

STUDY DESIGN:
The NOSTRA-Feasibility study is a prospective non-randomised, single-arm, multicentre, feasibility study for a proposed future phase III clinical trial. The recruitment target for this feasibility study is 150 patients over 18 months. It is anticipated that up to 30 sites in the UK will be opened to recruitment. The treatment period is anticipated to be 12 months followed by follow-up at 12 months and 5 years.

There are multiple aspects to this study and these are broken down in the sections below:

COLLECTION OF TUMOUR BED BIOPSIES:
Following neoadjuvant treatment, all patients will undergo multiple US-guided tumour bed core biopsies prior to surgery. Most patients will have 8 cores taken but it is recognised that in patients with small tumours, or if technical or patient issues dictate, not all 8 cores will be possible.

A fan of paired cores will be taken, working from the central (nipple) tumour margin across the tumour to the peripheral edge of the original tumour bed, as described below:
1. Two cores from the medial peripheral margin
2. Two cores from the central tumour bed medial to marker clip
3. Two cores from the central tumour bed lateral to marker clip
4. Two cores from the lateral peripheral margin

SURGERY:
All patients will proceed to surgery in the NOSTRA-Feasibility Study. Surgery should proceed when the Investigator is satisfied that the patient is sufficiently recovered from neoadjuvant chemotherapy, at the earliest 3 weeks after day 1 of the last cycle of chemotherapy, and ideally within 6 weeks of day 1 of the last cycle of chemotherapy. Surgery to the breast will be according to local protocol and finally determined after post-neoadjuvant Multidisciplinary Team meetings where all imaging and clinical factors will be reviewed. Appropriate surgical options will be discussed and agreed with patients as standard clinical practice.

CENTRAL HISTOPATHOLOGY REVIEW:
All material from the diagnostic core biopsies, surgical excision specimens (including axilla biopsy specimens and SLNB specimens) and protocol defined tumour bed core biopsies will be handled and reported in local laboratories as per UK NHS Breast Screening Programme and Royal College of Pathologists joint guidelines. Local pathologists will ensure that accurate documentation of block taking is included in the histology reports from the surgically excised lesions (as per UK guidelines) in order to allow the central review to re-assess and, for example, to determine tumour size in more than one dimension. All material will be sent to HBRC for storage prior to central histopathology review.

There will be a central histopathology review of all patients to determine pCR and RCB. The NOSTRA-Feasibility Study pathologists will review all material from the diagnostic core biopsies, surgical excision specimens (including axilla biopsy specimens and Sentinel Lymph Node Biopsy (SLNB) specimens) and protocol defined tumour bed core biopsies. The central review pathologists will record the RCB score and group, as this is not routine practice in the UK. pCR is defined on the basis of central histopathology review of the surgical slides.

TRANSLATIONAL RESEARCH:
Tissue samples from this study will be an invaluable research resource for future studies. Patients are asked to consent for any tissue remaining at the end of the study to be stored for use in other ethically approved research projects. Patients are asked to gift tumour samples stored in any NHS Trust that are surplus to clinical requirements to the study.

Upon completion of central histopathology review, the primary diagnostic core biopsies, surgical excision specimens (including axilla biopsy specimens and Sentinel Lymph Node Biopsy (SLNB) specimens) and protocol defined tumour bed core biopsies will be sent from the HBRC to the University of Edinburgh for research purposes.

BLOOD COLLECTION FOR ctDNA SUB-STUDY (OPTIONAL):
Patients willing to provide blood samples will be asked to provide informed consent to take part in the optional ctDNA substudy. If a patient is unwilling to take part in this aspect of the study, they are still permitted to enter the study.

For patient’s that have provided consent for the collection of blood samples, a blood sample should be obtained at three timepoints:
1. Prior to commencing neoadjuvant treatment (pre-cycle 1 of chemotherapy and dua-targeted anti-HER2 treatment)
2. Post-cycle 1 of neoadjuvant treatment
3. After surgery is complete (first visit to clinic post-surgery)

These timepoints should coincide with routine blood tests taken within clinic. Up to 70 ml of blood will be taken (9 ml in EDTA tube and 60 ml in ctDNA tubes). Sites are not required to process the blood samples. The blood samples should be packaged and shipped together with the Blood Sample Collection Form on the same day to the Institute of Cancer and Genomic Sciences, University of Birmingham.

PATIENT PATHWAY TO STUDY ENTRY:
Potential patients will be identified at the Multidisciplinary Team meeting in participating NHS hospitals. Tests performed to assess eligibility will be identical to those performed as part of standard care in the vast majority of hospitals (sites). Patients meeting the criteria for study entry will be given a Patient Information Sheet and if willing to participate will be asked to sign and date an Informed Consent Form.

Screening Visit:
As part of the screening process and to confirm eligibility, the following procedures will be undertaken as part of standard routine practice:
1. Diagnostic biopsy and ultrasound visible marker clip insertion
2. Medical history
3. Full physical examination including height and weight
4. Molecular biomarker (ER, PgR and HER2) status
5. Radiological measurement of primary breast tumour(s) by standard practice ultrasound and mammogram
6. Clinical tumour measurements (caliper)
7. Fine Needle Aspirate (FNA) or core biopsy of clinically or radiologically enlarged/abnormal axillary nodes is required to define involvement
8. TNM staging to exclude metastatic disease in accordance with standard early breast cancer practice according to local site policy
9. Left Ventricular Ejection Fraction (LVEF) measured by Echocardiogram (ECHO) or Multi gated Acquisition (MUGA) within 12 weeks prior to study entry
10. Eastern Co-operative Oncology Group (ECOG) performance status
11. Sentinel lymph node biopsy at clinician’s discretion and only if no abnormal lymph nodes detected on ultrasound
12. Biochemical screen (ALT or AST, ALP, Bilirubin, Urea, Creatinine, Sodium, Potassium, Estimated Glomerular Filtration Rate)
13. Pregnancy test for females of child-bearing potential
14. Routine full blood count to include haemoglobin, white blood cell count including differential count and platlets.

Patients with abnormal blood test results would be considered ineligible for the study. Investigators will be expected to maintain details of all patients screened for the NOSTRA-Feasibility Study on the Patient Screening/Enrolment Log.

Study Entry:
Patients will be registered into the study once eligibility is confirmed through screening assessments and patient has given written informed consent. Patient registration will be performed electronically via the electronic Remote Data Capture (eRDC) system developed by CRCTU. The Investigator must provide name of site and responsible Investigator, patient's initials, date of birth, patient's hospital number, date of informed consent and the intended treatment regimen option at the discretion of the treating clinician at registration. At the end of the registration process patients will be assigned a unique patient trial number.

All patients will receive neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment with trastuzumab and pertuzumab using approved combination regimes with established efficacy and tolerability at the discretion of the treating clinician. The three NICE approved treatment regimens are:

REGIMEN 1: 5-Fluorouracil 500mg/m2*, Epirubicin 100mg/m2, Cyclophosphamide 600mg/m2, cycle 1-3 with Pertuzumab 840mg cycle 1 and 420mg cycles 2 and 3 and Trastuzumab 8mg/kg cycle 1 and 6mg/kg cycle 2 and 3, three weekly (3 cycles)
Followed by Docetaxel with Pertuzumab and Trastuzumab:
Docetaxel 75mg/m2 cycle 4 escalating to 100mg/m2 in the absence of dose limiting toxicity for cycle 5 and 6 with Pertuzumab 420mg cycle 4-6 and Trastuzumab 6mg/kg cycles 4-6, three weekly (3 cycles)

REGIMEN 2: 5-Fluorouracil 500mg/m2*, Epirubicin 100mg/m2, Cyclophosphamide 600mg/m2, three weekly (3 cycles)
Followed by Docetaxel with Pertuzumab and Trastuzumab:
Docetaxel 75mg/m2 cycle 4 escalating to 100mg/m2 in the absence of dose limiting toxicity for cycle 5 and 6 with Pertuzumab 840mg cycle 4 and 420mg cycles 5 and 6 and Trastuzumab 8mg/kg cycle 4 and 6mg/kg cycles 5 and 6, three weekly (3 cycles)

REGIMEN 3: Docetaxel 75mg/m2 and Carboplatin AUC 6 with Pertuzumab 840mg cycle 1 and 420mg cycles 2-6 and Trastuzumab 8mg/kg cycle 1 and 6mg/kg cycles 2-6,three weekly (6 cycles)
*Omission of 5-Fluorouracil at the discretion of the treating Investigator

Adjuvant Treatment: Traztuzumab must be continued following completion of neoadjuvant chemotherapy regimen. All patients will continue with adjuvant trastuzumab to receive a total of 18 cycles, +/- radiotherapy

On completion of the registration process, an email to key personnel (including the Investigator, the person performing the registration and responsible pharmacist) will be sent via eRDC confirming patient’s entry into the study.
Ideally patients should be entered into the study as soon as possible and within a maximum of 9 weeks (unless by patient choice) from the initial core biopsy result. Chemotherapy should ideally start within two weeks of registration.

On-treatment assessments:
Prior to 1st cycle of neoadjuvant chemotherapy and anti-HER2 treatment: If the patient has provided consent to take part in the ctDNA substudy, a blood sample will be taken prior to commencing the first cycle of neoadjuvant treatment. This will be taken in conjunction with the routine blood samples.

Prior to each cycle of neoadjuvant chemotherapy and anti-HER2 treatment: The following assessments will be performed prior to day 1 of each cycle of neoadjuvant chemotherapy (excluding cycle 1) and are envisaged to be part of standard practice:
1. Vital signs (blood pressure, pulse, temperature)
2. Full blood count within 3 days prior to day 1 of each 3 weekly treatment cycle to include haemoglobin, white blood cell count including differential count and platelets
3. Biochemical screen within 3 days prior to treatment cycle to include ALT or AST, ALP, Bilirubin, Urea, Creatinine, Sodium and Potassium
4. Review of adverse events. CTCAE version 4.0 will be used to grade adverse events.
5. Clinical tumour measurement (calipers): This is not required unless there is a concern or at discretion of the Investigator

End of Cycle 3 of neoadjuvant chemotherapy and anti-HER2 treatment: A clinical tumour assessment by caliper is mandatory to confirm absence of early disease progression at the end of cycle 3 (i.e. prior to commencing cycle 4 treatment). LVEF will also be measured by ECHO or MUGA scan.

On completion of neoadjuvant chemotherapy and anti-HER2 treatment the following assessments will be performed:
1. Review of adverse events using CTCAE version 4.0
2. Clinical and radiological tumour measurement, which includes clinical measurement of breast tumour by calipers, radiological measurement of tumour(s) by ultrasound scan and mammogram
3. Axillary ultrasound will be performed and any abnormal nodes will be (re)sampled (by FNA or biopsy) under image control
4. LVEF measurement by ECHO or MUGA
5. Blood sample collection for those patients taking part in the optional ctDNA substudy

Surgery: All patients will be scheduled for surgery after completing cycle 6 of neoadjuvant chemotherapy and anti-HER2 treatment. Surgery to the breast will be according to local protocol and finally determined after post-neoadjuvant Multidisciplinary Team meetings where all imaging and clinical factors will be reviewed. Appropriate surgical options will be discussed and agreed with patients as standard clinical practice. All patients must have either a SLNB or an axillary lymph node clearance as part of their surgical procedure post-neoadjuvant treatment unless a pre-neoadjuvant SLNB was successfully performed and was negative. Blood sample will be taken at the first clinic visit after surgery for those patients taking part in the optional ctDNA substudy.

Adjuvant anti-HER2 treatment (adjuvant trastuzumab): Traztuzumab will be continued following completion of neoadjuvant chemotherapy regimen. All patients will continue with adjuvant trastuzumab to receive a total of 18 cycles, +/- radiotherapy following surgery. Cardiac monitoring will continue during the administration of adjuvant trastuzumab.

Follow-up: Patient participation will end upon completion of surgery. Sites will be asked to provide follow-up information at 12 months and 5 years from date of registration. The 12 month follow-up will be performed in clinic face to face. 5 year follow-up data will be collected in clinic face to face or via telephone assessments.

RESEARCH TIMETABLE:
Recruitment phase: It is anticipated that recruitment phase will take 18 months.
Follow-up: Follow-up at 12 months and at 5 years.

Planned final analysis: Analysis of the primary and available secondary outcomes will be performed once the last patient has completed surgery. Analysis of compliance to treatment will be performed once all patients have completed treatment and time to event analysis will be conducted once all patients have completed 5 years of follow up.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

1. The observed number of patients with false negative biopsies as a proportion of all those assessed will be reported as a proportion of all evaluable patients.
1.1. False negative biopsies are defined as the number of patients in which all core biopsies show no residual tumour but their surgical specimen does contain residual tumour.

Secondary outcome measures

1. Concordance between local and central histopathology reporting of pCR will bedefined as the number of patients whose initial local pathological assessment of pCR is confirmed by Central Histopathology Review.
2. Compliance with neoadjuvant and adjuvant treatment; will be assessed by calculating relative dose intensity taking into account of both reductions in dose and delays to treatment.
3. Time to local recurrence; defined as time in whole days from date of registration to local recurrence or death from any cause. Patients who are alive and without local recurrence at the time of analysis will be censored at the date last seen.
4. Time to distant recurrence; defined in whole days from date of registration to distant recurrence or death from any cause. Patients who are alive and without distant recurrence at the time of analysis will be censored at the date last seen.
5. Overall survival; defined in whole days as the date of registration to death from any cause. Patients alive at the time of analysis will be censored at the date last seen.
6. Re-evaluation of the primary outcome using the Central Histopathological Review determination of RCB to define false negative biopsies as RCB-0 or 1 (no tumour or minimal residual disease) in the core biopsies but RCB-2 or 3 in the surgical specimen. This will be reported as a proportion of all recruited patients.
7. Ability of the axillary lymph node assessments post-neoadjuvant chemotherapy to identify definitive axillary lymph node involvement determined by surgery histopathology. Sensitivity, specificity and false negative rates will be reported.

Overall trial start date

22/02/2016

Overall trial end date

31/01/2026

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patient with histological diagnosis of operable HER2-positive, ER-negative, early stage invasive breast cancer
2. Tumour size ≥ 1cm and visible on US (T1c to T4d)
3. Patient fit and willing to receive one of the three planned NICE approved treatment regimens in the opinion of the responsible clinician
4. Eastern Co-operative Group (ECOG) performance status of 0 or 1
5. Women of childbearing potential, prepared to adopt highly effective contraceptive measures if sexually active for at least 6 months after completion of study medication
6. Female, aged ≥ 18 years
7. Able to provide written informed consent for the study
8. Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Previous invasive breast cancer
2. Unequivocal evidence of distant metastatic disease at registration
3. Active malignancy of non-breast origin
4. Previous chemotherapy
5. Prior extensive radiotherapy (as judged by the Investigator) to bone marrow
6. Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen
7. Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator
8. Prior diagnosis of cardiac failure
9. Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality
10. Bleeding diathesis
11. Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications
12. Pregnant (female patients of child bearing potential must have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to study entry)
13. Patient lactating
14. Patients who have received live vaccine within 4 weeks of the date of study entry
15. Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up
16. Patient unfit and/or unwilling to undergo surgery
17. Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures

Recruitment start date

31/01/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Barnet Hospital
Wellhouse Lane
Barnet
EN5 3DJ
United Kingdom

Trial participating centre

Barts Cancer Institute
Queen Mary University of London, Charterhouse Square
London
EC1M 6BQ
United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Trial participating centre

Belfast City Hospital
51 Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Dumfries and Galloway Royal Infirmary
A75, Cargenbridge
Dumfries
DG2 8RX
United Kingdom

Trial participating centre

Llandough Hospital
Penlan Road, Llandough
Penarth
CF64 2XX
United Kingdom

Trial participating centre

Musgrove Park Hospital
Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Prince Philip Hospital
Bryngwyn Mawr
Llanelli
SA14 8QF
United Kingdom

Trial participating centre

Queen Elizabeth Hospital Birmingham
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Treliske
Truro
TR1 3LQ
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Southend University Hospital
Prittlewell Chase
Westcliff-on-Sea
SS0 0RY
United Kingdom

Trial participating centre

Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Western Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road, Wythenshawe
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Dr Birgit Whitman
Head of Research Governance and Integrity
Research Support Group
University of Birmingham
Aston Webb Building
Room 119
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

F. Hoffmann-La Roche

Alternative name(s)

Hoffman-La Roche, F. Hoffmann-La Roche Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/01/2019: The participant information sheet has been uploaded.