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