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


Phase 2
18 Years
N/A
Not Enrolling
Female
Hereditary Breast and Ovarian Cancer Syndrome

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Agnès HARDOUIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EXSAL

NCT ID:

NCT01333748

Start Date:

April 2010

Completion Date:

June 2012

Related Keywords:

  • Hereditary Breast and Ovarian Cancer Syndrome
  • breast cancer
  • ovarian cancer
  • BRCA 1 and BRCA 2
  • Ovarian Neoplasms

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