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NCT Number: NCT07737509

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Marsden NHS Foundation Trust - Drug Development Unit, Sutton, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: 15 years

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bindu Baikady

CONTACT

[email protected]

02034376033

Jessica Maudsley

CONTACT

[email protected]

+44 20 3437 6017

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Royal Marsden NHS Foundation Trust

Registry information

Official study title

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

Acronym: MC2

Important dates

Study start
2021
Primary completion
2036
Study completion
2036
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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