Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-28 @ 2:00 AM
Study NCT ID:
NCT01391351
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2011-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Search for Predictors of Therapeutic Response in Ovarian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2011-07-08', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'search for predictors of response to chemotherapy', 'timeFrame': '12 months after beginning treatment', 'description': 'the search for predictors of response to chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced by using (i) the miRNA profile of serum before treatment with chemotherapy and (ii) the identification of polymorphisms or SNPs (Single Nucleotide polymorphism) in particular genes involved in the metabolism of chemotherapy agents'}], 'secondaryOutcomes': [{'measure': 'profiling miRNA expression', 'timeFrame': '1 month', 'description': '\\- Characterization of the response to treatment with profiling miRNA expression after the first course of chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced'}, {'measure': 'study of changes in serum miRNA expression', 'timeFrame': '6 months', 'description': '\\- The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage', 'chemotherapy with Taxol and Carboplatin', 'predictors of therapeutic response', 'serum miRNA', 'identification of polymorphisms or SNPs (Single Nucleotide Polymorphism)'], 'conditions': ['Carcinoma of the Ovary', 'Fallopian Tube Cancer', 'Peritoneal Serous-type Advanced Stage']}, 'descriptionModule': {'briefSummary': 'In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cancer of the ovary, peritoneum or of the fallopian tube\n* Stage III or IV\n* Cancer of serous histology\n* Patients of any chemotherapy naive\n* Patients should receive treatment with chemotherapy for first line by Taxol- Carboplatin. Avastin is authorized in concomitant.\n* An initial surgery or through authorized\n* Patients who signed informed consent\n* Patients over the age of 18 years\n\nExclusion Criteria:\n\n* Patients being treated for another cancer chemotherapy and / or hormone therapy\n* Patients receiving other chemotherapy Taxol-carboplatin associated or not to avastin\n* Patients under guardianship\n* Previous history of pelvic radiotherapy\n* History of malignancy blood'}, 'identificationModule': {'nctId': 'NCT01391351', 'acronym': 'miRSa', 'briefTitle': 'Search for Predictors of Therapeutic Response in Ovarian Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced', 'orgStudyIdInfo': {'id': 'miRSa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Taxol and carboplatin', 'description': 'blood samples in patients receiving Taxol and carboplatin chemotherapy', 'interventionNames': ['Other: blood samples']}, {'type': 'OTHER', 'label': 'Taxol, carboplatin and avastin', 'description': 'blood samples in patients receiving Taxol, carboplatin chemotherapy with avastin', 'interventionNames': ['Other: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'OTHER', 'description': 'blood samples in patients receiving Taxol and carboplatin chemotherapy :\n\n* On Day 1 of the first course of chemotherapy\n* On Day 1 of the second course of chemotherapy\n* Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy\n* At the end of chemotherapy', 'armGroupLabels': ['Taxol and carboplatin']}, {'name': 'blood samples', 'type': 'OTHER', 'description': 'blood samples in patients receiving Taxol and carboplatin chemotherapy with avastin:\n\n* On Day 1 of the first course of chemotherapy\n* On Day 1 of the second course of chemotherapy\n* Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy\n* At the end of chemotherapy', 'armGroupLabels': ['Taxol, carboplatin and avastin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35 000', 'city': 'Rennes', 'state': 'Brittany Region', 'country': 'France', 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '14076', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'Centre François BACLESSE', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '44 000', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'country': 'France', 'facility': 'Centre Réné Gauducheau', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '59000', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Centre Oscar LAMBRET', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '76 000', 'city': 'Rouen', 'state': 'Seine Maritime', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Institut de cancerologie de la loire', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Institut CURIE', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Florence JOLY-LOBBEDEZ, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre François Baclesse'}, {'name': 'Sophie KRIEGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre François Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}