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

C

Centre Francois Baclesse

Status and phase

Completed
Phase 2

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Treatments

Genetic: blood collection

Study type

Interventional

Funder types

Other

Identifiers

NCT01333748
EXSAL
2009-A00833-54 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

530 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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:

  • Males
  • 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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

530 participants in 2 patient groups

patients group
Experimental group
Description:
Patients with ovarian and/or breast cancer
Treatment:
Genetic: blood collection
Genetic: blood collection
control population
Other group
Description:
control population without history of breast and/or ovarian cancer
Treatment:
Genetic: blood collection
Genetic: blood collection

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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