Understanding the Genetic and Biological Factors That Influence Cancer Treatment Response and Resistance in Patients With Advanced Solid Tumours Through Sample Analysis
MC2
Understanding the Molecular Pathways Underlying Drug Response and Resistance in Early Clinical Trials Through Tumour Molecular Characterisation
1 other identifier
observational
5,000
1 country
2
Brief Summary
The goal of this observational study is to attempt to find altered genetic 'switches' (mutations) in adults with advanced solid cancers who are being considered for, or are participating in, early-phase cancer clinical trials. Research has shown that cancer cells make use of key mutations to 'switch on' their growth, spread, and survival. This study will use this information to evaluate what happens to mutations over time which may help match patients to suitable clinical trials and support the development of more personalised cancer treatments. The main question it aims to answer is: Can mutations identified in various samples, including tumour samples and blood samples, help predict which patients are most likely to benefit from specific cancer treatments or clinical trials? Participants will provide consent to allow previously collected tumour samples, such as tissue from earlier biopsies or surgery, to be used for molecular analysis; allow researchers to collect and analyse clinical information about their cancer, treatments, clinical trial participation, and outcomes; be asked to provide optional research samples, which may include blood, urine, saliva, stool samples, cheek swabs, rectal swabs, tumour biopsies, and other bodily fluids when clinically appropriate; have tumour and other samples analysed to identify genetic and molecular changes that may influence cancer growth, treatment response, and treatment resistance; be informed if clinically significant findings are identified that may be relevant to their cancer care; and be followed over time through review of medical records to monitor clinical outcomes and the safety of research sample collection procedures, including biopsies. This study does not test a specific treatment. Information gained from the study may help researchers better understand cancer biology, identify new treatment targets, improve patient selection for future clinical trials, and support the development of personalised cancer therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2021
CompletedFirst Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2036
July 31, 2026
July 1, 2026
15.1 years
July 27, 2026
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To facilitate basic and translational research that includes the correlation of molecular abnormalities with corresponding trial participation and survival data, in order to develop and apply biomarkers for personalised medicine
15 years
Secondary Outcomes (3)
To identify molecular mechanisms that allow for exceptional response in our clinical trials by detailed analysis of samples from exceptional responders to generate hypotheses for future drug development.
15 years
To offer advanced cancer patients next generation sequencing (NGS) and/or immunohistochemistry (IHC) and other biomarker analysis of tumour tissue and/or blood samples
15 years
To prospectively collect ongoing data on the safety of collection of fresh tissue from research participants and report on serious medically significant events
15 years
Study Arms (1)
Patients with progressing advanced solid cancers.
Eligibility Criteria
Patients with advanced solid cancers who are considered eligible for clinical trials based on best medical practices in oncology.
You may qualify if:
- Histologically, cytologically or biochemically confirmed diagnosis of advanced solid cancer
- Older than or equal to 18 years of age
- Patients who are being considered for an early phase clinical trial or who are currently participating in an early phase clinical trial
- Written (signed and dated) informed consent.
You may not qualify if:
- N/A.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Royal Marsden NHS Foundation Trust - Drug Development Unit
Sutton, SM2 5PT, United Kingdom
Royal Marsden NHS Foundation Trust - Prostate Cancer Targeted Therapy Group
Sutton, SM2 5PT, United Kingdom
Biospecimen
Archival tumour tissue; fresh tumour biopsy; buccal smears; rectal smears; stool samples; blood samples; urine samples; saliva sample; ascetic sample; pleural fluid sample.
Study Officials
- STUDY DIRECTOR
Professor Johann de Bono
Institute of Cancer Research, United Kingdom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 30, 2026
Study Start
April 28, 2021
Primary Completion (Estimated)
June 1, 2036
Study Completion (Estimated)
June 1, 2036
Last Updated
July 31, 2026
Record last verified: 2026-07