Understanding the Genetic and Biological Factors That Influence Cancer Treatment Response and Resistance in Patients With Advanced Solid Tumours Through Sample Analysis (MC2)

July 30, 2026 updated by: Institute of Cancer Research, United Kingdom

Understanding the Molecular Pathways Underlying Drug Response and Resistance in Early Clinical Trials Through Tumour Molecular Characterisation

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.

Study Overview

Status

Recruiting

Conditions

Advanced Solid Tumours

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jessica Maudsley
Phone Number: +44 20 3437 6017
Email: MC2@icr.ac.uk

Study Contact Backup

Name: Bindu Baikady
Phone Number: 02034376033
Email: MC2@icr.ac.uk

Study Locations

United Kingdom
- - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - Royal Marsden NHS Foundation Trust - Drug Development Unit
    - Principal Investigator:
      
      Professor Johann de Bono
    - Contact:
      
      Professor Johann de Bono
      
      Phone Number: 02087224028
  - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - Royal Marsden NHS Foundation Trust - Prostate Cancer Targeted Therapy Group
    - Principal Investigator:
      
      Professor Johann de Bono
    - Contact:
      
      Professor Johann de Bono
      
      Phone Number: 02087224028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced solid cancers who are considered eligible for clinical trials based on best medical practices in oncology.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

N/A.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Patients with progressing advanced solid cancers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: 15 years	15 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 15 years	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 Time Frame: 15 years	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 Time Frame: 15 years	15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Royal Marsden NHS Foundation Trust

Investigators

Study Director: Professor Johann de Bono, Institute of Cancer Research, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Estimated)

June 1, 2036

Study Completion (Estimated)

June 1, 2036

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria