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

Primary Purpose

Breast Cancer, Transcriptomes, Molecular Diagnostic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
collection of a blood sample and breast and ovarian tissue
use of a previous blood collection for patients
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring splice profiles of messenger RNA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

For Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Clinique du Parc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control population : Healthy Volunteers

Patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
September 24, 2015
Last Updated
November 5, 2020
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT02560818
Brief Title
Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer
Acronym
CASOHAR
Official Title
Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study requires two steps: - The first part of the study will be conducted on a population of 20 women free of breast cancer and, or ovarian Family (healthy volunteers controls) and without a known family history of breast and or ovarian cancer. Mapping the level of blood (leukocytes) and the breast tissue will be drawn for the same individual on the physiological profiles splicing of the messenger RNA of genes involved in this predisposition, targeted by high-throughput sequencing of RNA (RNASeq). A direct comparison of RNA splicing patterns between blood and breast tissue from the same witness will detect any differences between these two tissues. -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 with no known family history of breast and, or ovarian cancer. Analysis of the results will highlight potential splicing abnormalities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Transcriptomes, Molecular Diagnostic, Ovarian Cancer
Keywords
splice profiles of messenger RNA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control population : Healthy Volunteers
Arm Type
Active Comparator
Arm Description
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
Arm Title
Patients
Arm Type
Experimental
Arm Description
blood samples of 50 patients will be used (use of blood collection in study EXSAL N°ID-RCB 2009-A00833-54)
Intervention Type
Other
Intervention Name(s)
collection of a blood sample and breast and ovarian tissue
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
use of a previous blood collection for patients
Primary Outcome Measure Information:
Title
Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching)
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
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).
Time Frame
at inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For Healthy Volunteers Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie KRIEGER, MD
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique du Parc
City
Caen
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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