Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Geavanceerde vaste tumoren

Studietype

Observationeel

Inschrijving (Geschat)

5000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Jessica Maudsley
Telefoonnummer: +44 20 3437 6017
E-mail: MC2@icr.ac.uk

Studie Contact Back-up

Naam: Bindu Baikady
Telefoonnummer: 02034376033
E-mail: MC2@icr.ac.uk

Studie Locaties

Verenigd Koninkrijk
- - Sutton, Verenigd Koninkrijk, SM2 5PT
    - Werving
    - Royal Marsden NHS Foundation Trust - Drug Development Unit
    - Hoofdonderzoeker:
      
      Professor Johann de Bono
    - Contact:
      
      Professor Johann de Bono
      
      Telefoonnummer: 02087224028
  - Sutton, Verenigd Koninkrijk, SM2 5PT
    - Werving
    - Royal Marsden NHS Foundation Trust - Prostate Cancer Targeted Therapy Group
    - Hoofdonderzoeker:
      
      Professor Johann de Bono
    - Contact:
      
      Professor Johann de Bono
      
      Telefoonnummer: 02087224028

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Patients with progressing advanced solid cancers.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
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 Tijdsspanne: 15 years	15 years

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
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. Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 15 years	15 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Institute of Cancer Research, United Kingdom

Medewerkers

Royal Marsden NHS Foundation Trust

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 april 2021

Primaire voltooiing (Geschat)

1 juni 2036

Studie voltooiing (Geschat)

1 juni 2036

Studieregistratiedata

Eerst ingediend

27 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria