- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00757263
Study of Genes and the Environment in Patients With Ovarian Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Ovarian Cancer in East Anglia, Oxford, Trent and West Midlands
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with ovarian cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- To obtain epidemiological information and biological material on a population-based series of ovarian cases.
- To define the proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2).
- To determine the risk associated with predisposing mutations by examining the cancer risks in relatives of patients who are shown to be carriers.
- To examine the effect of nongenetic risk factors in mutation carriers.
- To determine the pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers.
- To establish whether mutations at other loci may predispose to ovarian cancer by comparing the frequency of alterations in ovarian cancer patients with that in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
OUTLINE: This is a multicenter study.
Patients complete an epidemiological questionnaire. The questionnaire will request identifying information on the patient's first-degree relatives.
Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
In addition to the ovarian cancer patients recruited for this study, patients with breast, endometrial, prostate, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
England
-
Cambridge, England, Det Forenede Kongerige, CB1 8RN
- Rekruttering
- University of Cambridge Cancer Research UK
-
Kontakt:
- Contact Person
- Telefonnummer: 44-122-374-0166
- E-mail: paul.pharoah@srl.cam.ac.uk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Diagnosis of ovarian cancer within the past 5 years
Identified through the East Anglia, Stoke and West Midlands Cancer Registries serving any of the following geographic regions of the United Kingdom:
- East Anglia
- Oxford
- Trent
- West Midlands
PATIENT CHARACTERISTICS:
- Identified by the patient's general practitioner as fit to contact for this study
- No serious mental illness or retardation
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
|---|
|
Indhentning af epidemiologisk information og biologisk materiale
|
|
Proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2)
|
|
Risk associated with predisposing mutations
|
|
Effect of nongenetic risk factors in mutation carriers
|
|
Pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers
|
|
Exploration of mutations at other loci that may predispose to ovarian cancer
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Paul Pharoah, MD, Cancer Research UK
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
Andre undersøgelses-id-numre
- CDR0000598881
- MREC-07/MRE05/17
- MREC-SEARCH-OVARIAN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .