Clinical trial · Interventional
Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer
NCT02560818CI-TRIAL-00048193CASOHARcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Molecular Diagnostic | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Transcriptomes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| collection of a blood sample and breast and ovarian tissue | Other | — | UNRESOLVED |
| use of a previous blood collection for patients | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control population : Healthy Volunteers
- 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
- interventionNames
- Other: collection of a blood sample and breast and ovarian tissue
- type
- EXPERIMENTAL
- label
- Patients
- description
- blood samples of 50 patients will be used (use of blood collection in study EXSAL N°ID-RCB 2009-A00833-54)
- interventionNames
- Other: use of a previous blood collection for patients
Primary outcomes (1)
- measure
- Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.