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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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:

  1. Histologically, cytologically or biochemically confirmed diagnosis of advanced solid cancer
  2. Older than or equal to 18 years of age
  3. Patients who are being considered for an early phase clinical trial or who are currently participating in an early phase clinical trial
  4. 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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with progressing advanced solid cancers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Cancer Research, United Kingdom

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal Marsden NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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