Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT04654494
Status:
UNKNOWN
Last Update Posted:
2020-12-08
First Post:
2020-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colorectal Cancer in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016737', 'term': 'Proctocolectomy, Restorative'}], 'ancestors': [{'id': 'D003082', 'term': 'Colectomy'}, {'id': 'D000099090', 'term': 'Surgical Procedures, Colorectal'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000078542', 'term': 'Proctectomy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2020-11-29', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'percentage of patients alive'}, {'measure': 'disease free survival', 'timeFrame': '5 years', 'description': 'percentage of patients disease free'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal surgery'], 'conditions': ['Crohn Disease', 'Colorectal Cancer', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': "Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset.\n\nData will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible.\n\nThe study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR).\n\nPrimary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Crohn's disease complicated by occurrence of colorectal cancer, treated surgically between 01/2010 and 01/2020", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020\n\nExclusion Criteria:\n\n* Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis.\n* Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)"}, 'identificationModule': {'nctId': 'NCT04654494', 'briefTitle': "Colorectal Cancer in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': "Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures", 'orgStudyIdInfo': {'id': 'REGISTROSPERIMENTAZIONI120/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Chron's disease patients with colorectal cancer", 'description': "This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically", 'interventionNames': ['Procedure: Total proctocolectomy', 'Procedure: Total colectomy', 'Procedure: Segmental colectomy']}], 'interventions': [{'name': 'Total proctocolectomy', 'type': 'PROCEDURE', 'description': 'excision of the whole large bowel including colon and rectum and end ileostomy fashioning', 'armGroupLabels': ["Chron's disease patients with colorectal cancer"]}, {'name': 'Total colectomy', 'type': 'PROCEDURE', 'description': 'excision of the colon with preservation of the rectum', 'armGroupLabels': ["Chron's disease patients with colorectal cancer"]}, {'name': 'Segmental colectomy', 'type': 'PROCEDURE', 'description': 'excision of a segment of colon', 'armGroupLabels': ["Chron's disease patients with colorectal cancer"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Bruno Sensi, MD', 'role': 'CONTACT', 'email': 'brunosensi@outlook.it', 'phone': '3385352902'}, {'name': 'Giuseppe S Sica, MD, PhD', 'role': 'CONTACT', 'email': 'sigisica@gmail.com', 'phone': '3385333659'}], 'facility': 'Policlinico Tor Vergata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Bruno Sensi, MD', 'role': 'CONTACT', 'email': 'brunosensi@outlook.it', 'phone': '3385352902'}, {'name': 'Giuseppe S Sica, MD, PhD', 'role': 'CONTACT', 'email': 'sigisica@gmail.com', 'phone': '3385333659'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Head of Department', 'investigatorFullName': 'Giuseppe Sigismondo Sica', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}