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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 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Avanserte solide svulster

Studietype

Observasjonsmessig

Registrering (Antatt)

5000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

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

Studiesteder

Storbritannia
- - Sutton, Storbritannia, SM2 5PT
    - Rekruttering
    - Royal Marsden NHS Foundation Trust - Drug Development Unit
    - Hovedetterforsker:
      
      Professor Johann de Bono
    - Ta kontakt med:
      
      Professor Johann de Bono
      
      Telefonnummer: 02087224028
  - Sutton, Storbritannia, SM2 5PT
    - Rekruttering
    - Royal Marsden NHS Foundation Trust - Prostate Cancer Targeted Therapy Group
    - Hovedetterforsker:
      
      Professor Johann de Bono
    - Ta kontakt med:
      
      Professor Johann de Bono
      
      Telefonnummer: 02087224028

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Patients with progressing advanced solid cancers.

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
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 Tidsramme: 15 years	15 years

Sekundære resultatmål

Resultatmål	Tidsramme
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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 15 years	15 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institute of Cancer Research, United Kingdom

Samarbeidspartnere

Royal Marsden NHS Foundation Trust

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. april 2021

Primær fullføring (Antatt)

1. juni 2036

Studiet fullført (Antatt)

1. juni 2036

Datoer for studieregistrering

Først innsendt

27. juli 2026

Først innsendt som oppfylte QC-kriteriene