Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-10 @ 7:22 PM
Study NCT ID:
NCT02560818
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2015-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2015-09-24', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching)', 'timeFrame': 'at inclusion'}], 'secondaryOutcomes': [{'measure': '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).', 'timeFrame': 'at inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['splice profiles of messenger RNA'], 'conditions': ['Breast Cancer', 'Transcriptomes', 'Molecular Diagnostic', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This is a case-control study of molecular diagnostics.\n\nThis study requires two steps:\n\n* 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)\n* 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 .\n\nFor analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL study, ID-RCB 2009-A00833-54) will be used.', 'detailedDescription': 'This study requires two steps:\n\n\\- 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.\n\nMapping 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).\n\nA direct comparison of RNA splicing patterns between blood and breast tissue from the same witness will detect any differences between these two tissues.\n\n-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.\n\nAnalysis of the results will highlight potential splicing abnormalities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For Healthy Volunteers\n\nInclusion Criteria:\n\nFor population A\n\n* 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\n* Age 18-65 years\n* Women targeted for breast reduction surgery\n* Agreeing to participate in the study (collection of signed informed consent)\n\nFor population B\n\n* 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).\n* Women to be operated on for a hysterectomy with annexectomy or an annexectomy in a benign indication\n\nFor population C :\n\n* 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\n* Women who have been treated for breast cancer and undergoing contralateral symmetrization surgery\n\nExclusion Criteria:\n\n* Men\n* 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)\n* Population C: breast cancer under 50 years\n* Persons deprived of liberty or guardianship (including curatorship)'}, 'identificationModule': {'nctId': 'NCT02560818', 'acronym': 'CASOHAR', 'briefTitle': 'Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer', 'orgStudyIdInfo': {'id': 'CASOHAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control population : Healthy Volunteers', 'description': '20 Healthy Volunteers will be recruited:\n\n* 10 women to recover breast tissue (from surgical waste) : populations A and C\n* 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']}], 'interventions': [{'name': 'collection of a blood sample and breast and ovarian tissue', 'type': 'OTHER', '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)', 'armGroupLabels': ['Control population : Healthy Volunteers']}, {'name': 'use of a previous blood collection for patients', 'type': 'OTHER', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Sophie KRIEGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre François Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}