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

30 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Avancerade solida tumörer

Studietyp

Observationell

Inskrivning (Beräknad)

5000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Jessica Maudsley
Telefonnummer: +44 20 3437 6017
E-post: MC2@icr.ac.uk

Studera Kontakt Backup

Namn: Bindu Baikady
Telefonnummer: 02034376033
E-post: MC2@icr.ac.uk

Studieorter

Storbritannien
- - Sutton, Storbritannien, SM2 5PT
    - Rekrytering
    - Royal Marsden NHS Foundation Trust - Drug Development Unit
    - Huvudutredare:
      
      Professor Johann de Bono
    - Kontakt:
      
      Professor Johann de Bono
      
      Telefonnummer: 02087224028
  - Sutton, Storbritannien, SM2 5PT
    - Rekrytering
    - Royal Marsden NHS Foundation Trust - Prostate Cancer Targeted Therapy Group
    - Huvudutredare:
      
      Professor Johann de Bono
    - Kontakt:
      
      Professor Johann de Bono
      
      Telefonnummer: 02087224028

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Patients with progressing advanced solid cancers.

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
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 Tidsram: 15 years	15 years

Sekundära resultatmått

Resultatmått	Tidsram
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. Tidsram: 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 Tidsram: 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 Tidsram: 15 years	15 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Institute of Cancer Research, United Kingdom

Samarbetspartners

Royal Marsden NHS Foundation Trust

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 april 2021

Primärt slutförande (Beräknad)

1 juni 2036

Avslutad studie (Beräknad)

1 juni 2036

Studieregistreringsdatum

Först inskickad

27 juli 2026

Först inskickad som uppfyllde QC-kriterierna