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Clinical Trials/NCT01333748
NCT01333748CompletedPhase 2

Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer

Centre Francois Baclesse11 sites in 1 country530 target enrollmentStarted: April 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
530
Locations
11
Primary Endpoint
estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •For patients
  • •Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
  • •Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
  • •Age ≥ 18 years
  • •Agreeing to participate in the study (a collection of signed informed consent)
  • •For control population
  • •Women with no history of breast and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before 60 years for ovarian cancer
  • •Agreeing to participate in the study (a collection of signed informed consent)

Exclusion Criteria

  • •For patients:
  • •Patients with a known deleterious mutation in BRCA1 and BRCA2
  • •Patients do not meet criteria suggestive of a hereditary predisposition
  • •Persons deprived of liberty or under guardianship (including guardianship)
  • •For control population:
  • •Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
  • •Persons deprived of liberty or under guardianship (including guardianship)

Outcomes

Primary Outcomes

estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1

Time Frame: blood sample at baseline, no follow-up in this study

The main objective of this study is to estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1 in a population meeting the criteria suggestive of a hereditary predisposition to breast and / or ovarian cancer , and negative for deleterious mutations of BRCA 1 and BRCA 2.

Secondary Outcomes

  • Study the variability of the measurement of the allelic expression depending on the position of SNPs(blood sample at baseline, no follow-up in this study)
  • proportion of patients with allelic imbalance at the level of expression of the BRCA2 gene(blood sample at baseline, no follow-up in this study)
  • Observe the possible effect of age(blood sample at baseline, no follow-up in this study)

Investigators

Sponsor
Centre Francois Baclesse
Sponsor Class
Other

Study Sites (11)

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