Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer

NCT02560818 | Completed

• 1 other identifier: CASOHAR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a case-control study of molecular diagnostics. This study requires two steps:

• The first part of the study will be conducted on a population of 20 women without breast cancer and, or ovarian family (Healthy Volunteers controls)
• The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls . For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL study, ID-RCB 2009-A00833-54) will be used.

Conditions

Breast Cancer; Transcriptomes; Molecular Diagnostic; Ovarian Cancer

Keywords

splice profiles of messenger RNA

Outcome Measures

Primary Outcomes (1)

• Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching)

  at inclusion

Secondary Outcomes (1)

• Difference between the average rate of inclusion of exons (exon inclusion mean level) leukocyte messenger RNAs and, the mRNA of breast tissue in healthy women (with pairing).

  at inclusion

Study Arms (2)

Control population : Healthy Volunteers

ACTIVE COMPARATOR

20 Healthy Volunteers will be recruited: * 10 women to recover breast tissue (from surgical waste) : populations A and C * 10 women to recover ovarian tissue (from surgical waste) : population B

Other: collection of a blood sample and breast and ovarian tissue

Patients

EXPERIMENTAL

blood samples of 50 patients will be used (use of blood collection in study EXSAL N°ID-RCB 2009-A00833-54)

Other: use of a previous blood collection for patients

Interventions

collection of a blood sample and breast and ovarian tissue OTHER

a blood sample and a breast and ovarian tissue sample will be collected in healthy women during their surgery (breast or ovarian surgery according to selection group :A, B or C)

Control population : Healthy Volunteers

use of a previous blood collection for patients OTHER

Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For population A
• Women without a history of breast cancer 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 age 60 for ovarian cancer
• Age 18-65 years
• Women targeted for breast reduction surgery
• Agreeing to participate in the study (collection of signed informed consent)
• For population B
• Women over the age of 18, with no previous history of breast and / or ovarian cancer and no family history of breast and / or early ovarian cancer in first and second degree relatives, ( diagnosis before age 50 for breast cancer and before age 60 for ovarian cancer).
• Women to be operated on for a hysterectomy with annexectomy or an annexectomy in a benign indication
• For population C :
• Women with a history of breast cancer between 50 and 65 years of age but no history of ovarian cancer and no family history of breast and / or ovarian cancer in first- and second-degree relatives before 50 years of age breast cancer and before age 60 for ovarian cancer
• Women who have been treated for breast cancer and undergoing contralateral symmetrization surgery

You may not qualify if:

• Men
• Personal history (for population A and B) or family history (populations A, B, C) of breast and / or ovarian cancer (known breast or ovarian cancer in their family of 1st and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer)
• Population C: breast cancer under 50 years
• Persons deprived of liberty or guardianship (including curatorship)

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Clinique du Parc

Caen, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sophie KRIEGER, MD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

FR (1)