NCT01333748

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

April 4, 2011

Last Update Submit

July 12, 2012

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Keywords

breast cancerovarian cancerBRCA 1 and BRCA 2

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

patients group

EXPERIMENTAL

Patients with ovarian and/or breast cancer

Genetic: blood collection

control population

OTHER

control population without history of breast and/or ovarian cancer

Genetic: blood collection

Interventions

blood collectionGENETIC

blood collection for research quantification of allelic expression in the gene BRCA1.

patients group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dr Pascaline BERTHET

Caen, Caen, 14076, France

Location

Centre Eugène MARQUIS

Rennes, Rennes, 35 000, France

Location

Centre Hospitalier

Cherbourg, 50102, France

Location

CHU

Rennes, 35000, France

Location

Centre Henri BECQUEREL

Rouen, 76038, France

Location

CHU

Rouen, 76038, France

Location

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer SyndromeBreast NeoplasmsOvarian Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsNeoplastic Syndromes, HereditaryOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Agnès HARDOUIN, MD

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 12, 2011

Study Start

April 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

FR(6)