Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05696002
Status:
RECRUITING
Last Update Posted:
2023-01-25
First Post:
2023-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced Pelvic Surgical Oncology Database - Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D010386', 'term': 'Pelvic Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Not currently, but in the future, plans to study circulating immune cell/cytokine measurements, ctDNA, peritoneal macrophage/neutrophils, and existing protocols for biobanking of tumour samples/organoids'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-13', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer-specific survival', 'timeFrame': '10 years', 'description': 'Months'}, {'measure': 'Overall survival', 'timeFrame': '10 years', 'description': 'Months'}, {'measure': 'Post-operative complications', 'timeFrame': '10 years', 'description': 'Frequency'}, {'measure': 'Quality of life (survey)', 'timeFrame': '10 years', 'description': 'Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic exenteration', 'Abdominoperineal resection', 'Reconstructive flap', 'Rectal cancer'], 'conditions': ['Rectal Cancer', 'Pelvic Cancer', 'Gynecologic Cancer', 'Colon Cancer']}, 'descriptionModule': {'briefSummary': 'Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.\n\nGoal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.', 'detailedDescription': 'Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.\n\nGoal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Tertiary referral centre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced pelvic oncological resection defined as more than 1 pelvic organ resected\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05696002', 'briefTitle': 'Advanced Pelvic Surgical Oncology Database - Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Glasgow Royal Infirmary'}, 'officialTitle': 'Advanced Pelvic Surgical Oncology Database - Prospective Observational Study', 'orgStudyIdInfo': {'id': 'APSOD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced pelvic oncological resection', 'description': 'Complex resection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Norman Galbraith, MSc PhD MRCS', 'role': 'CONTACT', 'phone': '07449784948'}, {'name': 'Norman Galbraith, PhD MRCS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Academic Department of Surgery, Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Norman Galbraith, PhD MRCS', 'role': 'CONTACT', 'email': 'norman.galbraith@glasgow.ac.uk', 'phone': '07449784948'}, {'name': 'Colin Steele, PhD FRCS', 'role': 'CONTACT', 'email': 'colin.steele@glasgow.ac.uk', 'phone': '07449784948'}], 'overallOfficials': [{'name': 'Colin Steele, PhD FRCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glasgow Royal Infirmary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glasgow Royal Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'NES/CSO Clinical Lecturer in Surgery', 'investigatorFullName': 'Norman Galbraith', 'investigatorAffiliation': 'Glasgow Royal Infirmary'}}}}