Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-29 @ 5:24 PM
Study NCT ID:
NCT05523804
Status:
UNKNOWN
Last Update Posted:
2022-08-31
First Post:
2022-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '15 years', 'description': 'defined from date of diagnosis to date of death by any cause or loss to follow-up'}, {'measure': 'progression free survival', 'timeFrame': '15 years', 'description': 'defined from date of diagnosis to date of first recurrence'}, {'measure': 'facilitator/barriers to access to cytoreductive surgery', 'timeFrame': '15 years', 'description': 'topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally'}], 'secondaryOutcomes': [{'measure': 'Post-operative morbidity', 'timeFrame': 'within 30 days from date of surgery', 'description': 'as per Clavien-Dindo classification'}, {'measure': 'Resectability rates', 'timeFrame': 'at time of surgery', 'description': 'R0 = no visible disease, R1 = \\<10mm visible residual disease, R2 = \\>10mm visible residual disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['survival', 'morbidity', 'cytoreduction', 'disparities'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '36379595', 'type': 'DERIVED', 'citation': 'Gaba F, Ash K, Blyuss O, Bizzarri N, Kamfwa P, Ramirez PT, Kotsopoulos IC, Chandrasekaran D, Gomes N, Butler J, Nobbenhuis M, Ind T, Heath O, Barton D, Jeyarajah A, Brockbank E, Lawrence A, Dilley J, Manchanda R, Phadnis S, Soar GO. Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative). Int J Gynecol Cancer. 2022 Dec 5;32(12):1606-1610. doi: 10.1136/ijgc-2022-004101.'}]}, 'descriptionModule': {'briefSummary': 'To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.', 'detailedDescription': 'Standard of care in patients with advanced ovarian cancer is primary cytoreductive surgery followed by chemotherapy. Neoadjuvant chemotherapy and interval cytoreductive surgery is an alternative in selected patients. Most data exist with interval cytoreductive surgery following 3-4 cycles of chemotherapy, however, some patients experience a delay. So far, the impact of delayed cytoreductive surgery (following \\>5 cycles of chemotherapy) on patient outcomes is poorly defined. There is also a paucity of data in women who undergo no surgery (\\>5 cycles of chemotherapy alone) and factors influencing international discrepancies in access to cytoreductive surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women with stage III-IV ovarian cancer', 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (\\>5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (\\>5 cycles of chemotherapy alone.\n\nExclusion Criteria:\n\nWomen undergoing recurrent cytoreductive surgery.'}, 'identificationModule': {'nctId': 'NCT05523804', 'acronym': 'GO SOAR2', 'briefTitle': 'Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Grampian'}, 'officialTitle': 'Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)', 'orgStudyIdInfo': {'id': '5719'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'interval cytoreductive surgery', 'description': 'women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery', 'interventionNames': ['Procedure: interval cytoreductive surgery']}, {'label': 'delayed cytoreductive surgery', 'description': 'women with stage III-IV ovarian cancer, undergoing delayed (\\>5 cycles of chemotherapy) cytoreductive surgery', 'interventionNames': ['Procedure: delayed cytoreductive surgery']}, {'label': 'no surgery', 'description': 'women with stage III-IV ovarian cancer, undergoing \\>5 cycles of chemotherapy alone (no cytoreductive surgery)', 'interventionNames': ['Other: no surgery']}], 'interventions': [{'name': 'interval cytoreductive surgery', 'type': 'PROCEDURE', 'description': 'cytoreductive surgery after 3-4 cycles of chemotherapy', 'armGroupLabels': ['interval cytoreductive surgery']}, {'name': 'delayed cytoreductive surgery', 'type': 'PROCEDURE', 'description': 'surgery after \\>5 cycles of chemotherapy', 'armGroupLabels': ['delayed cytoreductive surgery']}, {'name': 'no surgery', 'type': 'OTHER', 'description': 'no cytoreductive surgery (\\>5 cycles of chemotherapy alone)', 'armGroupLabels': ['no surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1FR', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Faiza Gaba', 'role': 'CONTACT', 'email': 'faiza.gaba1@abdn.ac.uk', 'phone': '+442035942053'}], 'facility': 'The Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Faiza Gaba', 'role': 'CONTACT', 'email': 'faiza.gaba1@abdn.ac.uk', 'phone': '+442035942053'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Grampian', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Aberdeen', 'class': 'OTHER'}, {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, {'name': 'Queen Mary University of London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Faiza Gaba', 'investigatorAffiliation': 'University of Aberdeen'}}}}