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 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
5000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jessica Maudsley
- Telefonnummer: +44 20 3437 6017
- E-mail: MC2@icr.ac.uk
Undersøgelse Kontakt Backup
- Navn: Bindu Baikady
- Telefonnummer: 02034376033
- E-mail: MC2@icr.ac.uk
Studiesteder
-
-
-
Sutton, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- Royal Marsden NHS Foundation Trust - Drug Development Unit
-
Ledende efterforsker:
- Professor Johann de Bono
-
Kontakt:
- Professor Johann de Bono
- Telefonnummer: 02087224028
-
Sutton, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- Royal Marsden NHS Foundation Trust - Prostate Cancer Targeted Therapy Group
-
Ledende efterforsker:
- Professor Johann de Bono
-
Kontakt:
- Professor Johann de Bono
- Telefonnummer: 02087224028
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Patients with progressing advanced solid cancers.
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studieleder: Professor Johann de Bono, Institute of Cancer Research, United Kingdom
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. april 2021
Primær færdiggørelse (Anslået)
1. juni 2036
Studieafslutning (Anslået)
1. juni 2036
Datoer for studieregistrering
Først indsendt
27. juli 2026
Først indsendt, der opfyldte QC-kriterier
27. juli 2026
Først opslået (Faktiske)
30. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 5244
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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