Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-03-05 @ 7:35 PM
Study NCT ID:
NCT01788995
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2013-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010534', 'term': 'Peritoneal 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': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical/demographic patient characteristics at initiation of treatment', 'timeFrame': 'approximately 4 years'}, {'measure': 'Duration of treatment', 'timeFrame': 'approximately 4 years'}, {'measure': 'Treatment discontinuations/modifications', 'timeFrame': 'approximately 4 years'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 4 years'}, {'measure': 'Progression-free survival', 'timeFrame': 'approximately 4 years'}]}, 'conditionsModule': {'conditions': ['Ovarian Cancer, Peritoneal Neoplasms']}, 'descriptionModule': {'briefSummary': 'This non-interventional study will evaluate the routine use and the safety and efficacy of Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas) with indication for carboplatin/paclitaxel chemotherapy in combination with Avastin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Patients with newly diagnosed advanced epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC) with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin\n\nExclusion Criteria:\n\n* Contraindications for Avastin according to the Summary of Product Characteristics'}, 'identificationModule': {'nctId': 'NCT01788995', 'briefTitle': 'BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Non-interventional Trial With Avastin as Front-line Treatment for Ovarian Cancer', 'orgStudyIdInfo': {'id': 'ML28355'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}