Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-29 @ 12:16 PM
Study NCT ID:
NCT06165328
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood for CBC, Coagulogram, BUN, Creatinine, Electrolyte, Iron study, CEA Stool for FIT test pathologic obtained (in case with polyp or malignancy)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 241}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2023-12-02', 'studyFirstSubmitQcDate': '2023-12-02', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield in diagnosis colorectal tumor', 'timeFrame': '2 weeks', 'description': 'Sensitivity, specitivity, accuracy'}], 'secondaryOutcomes': [{'measure': 'Procedure-related adverse events', 'timeFrame': '2 weeks', 'description': 'Procedure-related adverse events such as, contrast induced nephropathy, contrast allergy, colonoscope-related perforation, post polypectomy bleeding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal tumor', 'colorectal cancer', 'CT scan', 'colonoscopy'], 'conditions': ['Patients at Risk of Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '35505243', 'type': 'RESULT', 'citation': 'Shaukat A, Levin TR. Current and future colorectal cancer screening strategies. Nat Rev Gastroenterol Hepatol. 2022 Aug;19(8):521-531. doi: 10.1038/s41575-022-00612-y. Epub 2022 May 3.'}, {'pmid': '30665995', 'type': 'RESULT', 'citation': 'Wong MCS, Chan FKL. Colorectal cancer screening in middle eastern countries: Current status and future strategies to enhance screening. Saudi J Gastroenterol. 2019 Jan-Feb;25(1):1-2. doi: 10.4103/sjg.SJG_611_18. No abstract available.'}, {'pmid': '37497916', 'type': 'RESULT', 'citation': 'Tanaka H, Oka S, Shiotani A, Sugimoto M, Suzuki H, Naito Y, Handa O, Hisamatsu T, Fukudo S, Fujishiro M, Motoya S, Yahagi N, Yamaguchi S, Chan FKL, Lee SY, Li B, Ang TL, Abdullah M, Tablante MC, Prachayakul V, Tanaka S; International Gastrointestinal Consensus Symposium Study Group. Current Status of Diagnosis and Treatment of Colorectal Cancer in Asian Countries: A Questionnaire Survey. Digestion. 2024;105(1):62-68. doi: 10.1159/000531706. Epub 2023 Jul 27.'}, {'pmid': '17114203', 'type': 'RESULT', 'citation': "Ganeshan A, Upponi S, Uberoi R, D'Costa H, Picking C, Bungay H. Minimal-preparation CT colon in detection of colonic cancer, the Oxford experience. Age Ageing. 2007 Jan;36(1):48-52. doi: 10.1093/ageing/afl116. Epub 2006 Nov 17."}, {'pmid': '16565655', 'type': 'RESULT', 'citation': 'Pilleul F, Bansac-Lamblin A, Monneuse O, Dumortier J, Milot L, Valette PJ. Water enema computed tomography: diagnostic tool in suspicion of colorectal tumor. Gastroenterol Clin Biol. 2006 Feb;30(2):231-4. doi: 10.1016/s0399-8320(06)73158-x.'}, {'pmid': '33682302', 'type': 'RESULT', 'citation': 'Miller J, Maeda Y, Au S, Gunn F, Porteous L, Pattenden R, MacLean P, Noble CL, Glancy S, Dunlop MG, Din FVN. Short-term outcomes of a COVID-adapted triage pathway for colorectal cancer detection. Colorectal Dis. 2021 Jul;23(7):1639-1648. doi: 10.1111/codi.15618. Epub 2021 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy is the mainstay modality of choice in colorectal cancer screening worldwide. However, the rate of colonoscopy for colorectal cancer screening is very low (approximately 5-10%) because of the limited local medical resources (such as endoscopists and regional endoscope). This observational diagnostic test study aims to compare the diagnostic yield of routine computed tomography and colonoscopy in detecting colorectal tumors in patients at risk of colorectal cancer (aged more than 50 years and FIT+). The main question\\[s\\] it aims to answer are:\n\n1. To compare the diagnostic yield between the routine computed tomography and colonoscopy.\n2. To compare the procedure-related adverse events between the routine computed tomography and colonoscopy.', 'detailedDescription': 'All enrolled patients underwent routine CT scans of whole abdomen, then subsequently under went a colonoscopy on the next day'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged 50-70 years old who underwent FIT test for an indication of colorectal cancer screening as National program of Thailand.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fit test +\n2. Normal platelet count and normal result of PT, PTT\n\nExclusion Criteria:\n\n1. pregnancy or lactation\n2. uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure\n3. recent coronary artery disease within 3 months\n4. eGFR lesser than 30 mL/min/1.73m2\n5. hemophilia or uncontrolled or uncorrected coagulopathy'}, 'identificationModule': {'nctId': 'NCT06165328', 'acronym': 'CTOCOCREC', 'briefTitle': 'The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+', 'organization': {'class': 'OTHER', 'fullName': 'Hat Yai Medical Education Center'}, 'officialTitle': 'The Comparison of Diagnostic Yield Between Routine Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients Who at Risk of Colorectal Cancer', 'orgStudyIdInfo': {'id': 'HYH EC 093-66-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort1', 'description': 'Patients with aged more than 50 years and had FIT test +', 'interventionNames': ['Diagnostic Test: CT and colonoscopy']}], 'interventions': [{'name': 'CT and colonoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients were admitted and worked up as inpatient cases. A blood test was obtained and a CT whole abdomen was performed for all patients in the evening. On the next day, all patients were prescribed for bowel preparation in the morning, then subsequently underwent colonoscopy in the afternoon.', 'armGroupLabels': ['Cohort1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Arunchai Chang, MD', 'role': 'CONTACT', 'email': 'busmdcu58@gmail.com', 'phone': '+66650979414'}], 'facility': 'Hatyai Hospital', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'centralContacts': [{'name': 'Arunchai Chang, MD', 'role': 'CONTACT', 'email': 'busmdcu58@gmail.com', 'phone': '+66650979414'}, {'name': 'Araya Kaimook, MD', 'role': 'CONTACT', 'email': 'araya@cpird.in.th', 'phone': '+66815424454'}], 'overallOfficials': [{'name': 'Arunchai Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Gastroenetrology, Department of Internal Medicine, Hatyai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hat Yai Medical Education Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'HatYai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Division of Gastroenterology, Department of Internal Medicine, Hatyai Hospital', 'investigatorFullName': 'Arunchai Chang', 'investigatorAffiliation': 'Hat Yai Medical Education Center'}}}}