Condition category
Cancer
Date applied
25/11/2019
Date assigned
10/12/2019
Last edited
10/12/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The Liverpool Experimental Cancer Medicine Centre (LECMC) seeks to support early phase clinical trials and laboratory-based cancer research in Liverpool, and through the ECMC network, more widely throughout the UK. One of the key strategic areas and objectives of the LECMC is to identify novel biomarkers of efficacy, resistance and drug safety in cancers including those of the pancreas, head and neck and breast. In order to achieve this, the scientists and clinicians within the LECMC need good quality prospective samples with linked data on treatments, side effects and outcomes. The biomarker discovery programme involves research groups within the University of Liverpool with interests in key strategic areas of the LECMC. The programme will involve collection of samples from patients with cancer or pre-cancerous disease relevant to each of these groups for usage in research projects, specifically for the purpose of investigating biomarkers for cancers. The aim of the programme is to enable research which would identify biological markers for surgical outcomes, responses to therapy and early diagnosis from a variety of sources; with a goal of leading to the development of personalised treatment regimes, stratification of patients and development of preventative approaches to cancers.

Who can participate?
Individuals over 18, with any of the following:
1. Suspected or actual diagnosis of cancer of the head and neck or pre-cancerous oral conditions and individuals who have been treated for these conditions in the past
2. Suspected or actual diagnosis of pancreatic cancer and individuals who have been treated for pancreatic cancer in the past
3. Confirmed early, locally advanced or metastatic breast cancer

What does the study involve?
The study involves providing biological samples and clinical information at different stages of cancer treatment.

What are the possible benefits and risks of participating?
The programme is not expected to affect the current treatment of any individual participant or directly benefit them. However, it is intended that this work will lead to new ways of diagnosing, monitoring and treating cancer. Most samples are intended to be collected at the same time as a planned medical procedure so no risks above those expected in standard medical care are expected. Biopsy samples may cause a level of discomfort. These samples are optional.

Where is the study run from?
The study is co-ordinated by the Liverpool Clinical Trials Centre (UK)

When is the study starting and how long is it expected to run for?
The study is due to start recruitment in December 2019. Initially it will continue until March 2022, with a view to continue past this date.

Who is funding the study?
Liverpool Experimental Cancer Medicine Centre (UK)

Who is the main contact?
Mrs Sara Martin

Trial website

Contact information

Type

Public

Primary contact

Mrs Sara Martin

ORCID ID

Contact details

Liverpool Clinical Trials Centre
University of Liverpool
1st Floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)151 794 8333
livecmc@liverpool.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 41118

Study information

Scientific title

Liverpool Experimental Cancer Medicine Centre (LECMC) biomarker discovery programme and prospective sample collection

Acronym

Study hypothesis

The Liverpool Experimental Cancer Medicine Centre (LECMC) seeks to support early phase trials and translational science in Liverpool, and through the ECMC network, more widely throughout the UK. One of the key strategic areas and objectives of the LECMC is to identify novel biomarkers of efficacy, resistance and drug safety in cancers including those of the pancreas, head and neck and breast. In order to achieve this, the scientists and clinicians within the LECMC need good quality prospective samples with linked data on treatments, side effects and outcomes.

The researchers intend to initiate a broad programme for biomarker discovery involving, initially, three research groups within the University of Liverpool with interests in key strategic areas of the LECMC. These are the Mersey Head and Neck Oncology Research Group, the Pancreatic Cancer Research Group and the Breast Cancer Research Group. The researchers would like to collect appropriate samples from patients with cancer or pre-cancerous disease relevant to each of these groups for usage in research projects, specifically for the purpose of investigating biomarkers for cancers. In doing so they hope to enable research which would identify markers for surgical outcomes, responses to therapy and early diagnosis from a variety of sources; with a goal of leading to the development of personalised treatment regimes, stratification of patients and development of preventative approaches to cancers.

Ethics approval

Approved 03/07/2019, North West – Liverpool East Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; Tel: +44 (0)207 104 8345; Email: nrescommittee.northwest-liverpooleast@nhs.net), REC ref: 19/NW/0298

Study design

Non-randomised; Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Pancreas, head and neck and breast cancer

Intervention

Methodology depends upon the research strand in question and the specific condition that the patient has. However for every visit for each part of the programme the relevant clinical and sample details will be recorded in a strand-specific and condition-specific manner on REDCap (the LCTU REDCap system is a web-based application that can be used for collecting and collating clinical data securely in a manner that is straightforward and easy to understand for site staff, storing the data in a secure database at LCTU).

Most samples will be taken alongside either routine clinical care or medically-advised procedures. Samples taken outside of specific medical procedures already taking place are typically either non-invasive (such as saliva) or minimally invasive (such as blood). The only exception to this is the Head & Neck - Post Treatment Toxicity which includes the possibility of taking biopsied tissue samples outside of normal clinical procedures and medically-advised procedures. Some samples are from archived or diagnostically-taken Formalin-Fixed Paraffin-Embedded (FFPE) tissue. Tissue is typically tumour, however, there are some cases where adjacent areas (for comparative purposes) or areas affected by treatment are taken.

All samples are voluntary and patients are able to refuse or agree to provide any or all samples at any or all specific points in the programme pathway.

Summary of research strands and branches as follows:

Head & Neck - Cancer Presumed Diagnosis:
1. Patient undergoes the informed consent procedure, signing a consent form; and is recruited to the programme.
2. Pre-surgical samples taken - blood and saliva.
3. Samples recovered from archive (where available) - tissue.
4. Intra-surgery, biopsy, or scrape samples - tissue and blood.
5. Follow-up visits including sample collection (blood, saliva plus samples from any further biopsies taken), or clinical follow-up visits with data only (in which case no samples are taken and only the relevant clinical data is recorded on REDCap).
6. End of involvement in the study (which can be the end of the programme period, patient death or patient withdrawal) - data entry only. End of involvement recorded on REDCap and final data entered. LECMC is informed via e-mail where applicable (e.g. for notification of withdrawal).

Head & Neck - Cancer Known Diagnosis:
1. Patient undergoes the informed consent procedure, signing a consent form; and is recruited to the programme.
2. Pre-surgical samples taken - blood and saliva.
3. Samples recovered from archive (where available) - tissue.
4. Intra-surgery, biopsy, or scrape samples - tissue and blood.
5. Follow-up visits including sample collection (blood, saliva plus samples from any further biopsies taken), or clinical follow-up visits with data only (in which case no samples are taken and only the relevant clinical data is recorded on REDCap).
6. End of involvement in the study (which can be the end of the programme period, patient death or patient withdrawal) - data entry only. End of involvement recorded on REDCap and final data entered. LECMC is informed via e-mail where applicable (e.g. for notification of withdrawal).

Head & Neck - Post-Treatment Toxicity:
1. Patient undergoes the informed consent procedure, signing a consent form; and is recruited to the programme.
2. Pre-surgical samples - blood and saliva.
3. From archive - tissue (where available).
4. Biopsy of affected sites - tissue, blood and saliva.
5. At treatment - blood and saliva.
6. Follow-up visits including sample collection (blood, saliva plus samples from any further biopsies taken) or clinical follow-up visits with data only (in which case no samples are taken and only the relevant clinical data is recorded on REDCap).
7. End of involvement in the study (which can be the end of the programme period, patient death or patient withdrawal) - data entry only. End of involvement recorded on REDCap and final data entered. LECMC is informed via e-mail where applicable (e.g. for notification of withdrawal).

Pancreas - Surgical:
1. Patient undergoes the informed consent procedure, signing a consent form; and is recruited to the programme.
2. Pre-surgical samples taken - blood, urine and previously taken tissue (where available).
3. Samples taken during surgery - tissue (from a Tru-Cut biopsy), bile and pancreatic juice.
4. Follow-up/adjuvant treatment visits including sample collection (blood and urine), or clinical follow-up visits with data only (in which case no samples are taken and only the relevant clinical data is recorded on REDCap).
5. Recurrence (where applicable) - blood, tissue and urine.
6. End of involvement in the study (which can be the end of the programme period, patient death or patient withdrawal) - data entry only. End of involvement recorded on REDCap and final data entered. LECMC is informed via e-mail where applicable (e.g. for notification of withdrawal).

Pancreas - Non-Surgical:
1. Patient undergoes the informed consent procedure, signing a consent form; and is recruited to the programme.
2. Diagnosis samples - blood, urine and tissue (where available)
3. Archived diagnostic samples - taken from pre-existing archived tissue.
4. Pre-treatment samples - blood and urine.
5. During treatment/follow-up visits including sample collection (blood and urine) or clinical follow-up visits with data only (in which case no samples are taken and only the relevant clinical data is recorded on REDCap).
6. Recurrence (where applicable) - blood, urine and tissue.
7. End of involvement in the study (which can be the end of the programme period, patient death or patient withdrawal) - data entry only. End of involvement recorded on REDCap and final data entered. LECMC is informed via e-mail where applicable (e.g. for notification of withdrawal).

Breast - Early Stage Breast Cancer:
1. Patient undergoes the informed consent procedure, signing a consent form; and is recruited to the programme.
2. Baseline - blood.
3. Tumour biopsy (FFPE tissue block), or tumour tissue from surgery (FFPE block).
4. Follow-up visits including sample collection (blood) or clinical follow-up visits with data only (in which case no samples are taken and only the relevant clinical data is recorded on REDCap).
5. On disease progression (blood), or upon non-CNS recurrence (blood and FFPE tissue).
6. End of involvement in the study (which can be the end of the programme period, patient death or patient withdrawal) - data entry only. End of involvement recorded on REDCap and final data entered. LECMC is informed via e-mail where applicable (e.g. for notification of withdrawal).

Breast - Breast Cancer with CNS Involvement:
1. Patient undergoes the informed consent procedure, signing a consent form; and is recruited to the programme.
2. Baseline - blood.
3. Primary tumour biopsy - FFPE tissue block.
4. Lumbar puncture (if taken) - cerebrospinal fluid.
5. Brain metastasis biopsy - blood, tissue and cerebrospinal fluid.
6. Follow-up visits including sample collection (blood), or clinical follow-up visits with data only (in which case no samples are taken and only the relevant clinical data is recorded on REDCap).
7. On disease progression (blood), or upon non-CNS recurrence (blood and FFPE tissue).
8. End of involvement in the study (which can be the end of the programme period, patient death or patient withdrawal) - data entry only. End of involvement recorded on REDCap and final data entered. LECMC is informed via e-mail where applicable (e.g. for notification of withdrawal).

Intervention type

Other

Phase

Drug names

Primary outcome measure

The primary outcome measure for this programme will be the number of publications produced by research projects supported by the programme. Each project supported by the programme will have its own outcome measures which will be considered by the programme management team during the project adoption process.

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/02/2018

Overall trial end date

31/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

This will vary according to tumour type. In general, the populations will consist of patients undergoing standard diagnosis and treatment for malignancies and premalignant disease in disease areas which are of interest to the LECMC. All patients must, in addition to fulfilling the medical requirements, complete an informed consent procedure including the physical signing of a consent form.

Head and Neck:
Presumptive or acute diagnosis of head and neck squamous cell cancer (HNSCC) or recognised oral premalignant conditions (OPML) including but not exhaustively oral epithelial dysplasia (OED), proliferative verrucous leucoplakia (PVL), and those individuals who have been treated for these conditions in the past.

Pancreas:
All patients with suspected or actual diagnosed Pancreatic Ductal Adenocarcinoma (PDAC), and those individuals who are undergoing or have been treated for PDAC in the past.

Breast:
Samples from all patients with histologically and/or cytologically confirmed early, locally advanced or metastatic breast cancer including patients with central nervous system (CNS) involvement defined as metastases to the brain parenchyma, metastases to the leptomeninges and/or paraneoplastic disorders.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1500; UK Sample Size: 1500

Participant exclusion criteria

1. Individuals who are unable to consent
2. Under 18 years of age
3. Unable to read or translate patient information sheet and/or consent form

Recruitment start date

01/01/2020

Recruitment end date

31/01/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool and Broadgreen University Hospitals NHS Trust
Royal Liverpool University Hospital Prescot Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

The Clatterbridge Cancer Centre NHS Foundation Trust
Clatterbridge Road
Bebington
CH63 4JY
United Kingdom

Trial participating centre

Aintree University Hospital NHS Foundation Trust
University Hospital Aintree Fazakerley Hospital Lower Lane
Liverpool
L9 7AL
United Kingdom

Trial participating centre

The Walton Centre NHS Foundation Trust
Lower Lane
Liverpool
L9 7LJ
United Kingdom

Sponsor information

Organisation

University of Liverpool

Sponsor details

c/o Mr Alex Astor
Research Support Office
2nd Floor Block D Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)1517948739
sponsor@liv.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK; Grant Codes: C52547/A28210

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Peer-reviewed scientific journals
2. Internal report
3. Conference presentation
4. Publication on website

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

31/03/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/11/2019: Trial's existence confirmed by the NIHR.