Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-31 @ 4:15 PM
Study NCT ID:
NCT03336658
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-13
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumor buds will be Immunohistochemically stained with a pancytokeratin marker'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2017-11-06', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation of ITB based calculated N stage with real N stage in CRC - patients', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'correlation of ITB based calculated DFS with real DFS in CRC - patients', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CRC']}, 'descriptionModule': {'briefSummary': 'All the preoperative biopsies of patients suffering colorectal cancer (CRC) will be immunohistochemically stained with a pancytokeratin marker to detect Tumor buds. then, the intratumoral buds (ITB) in the densest Region of Tumor buds, namely the "hot spot" will be counted. Subsequently, the probability of N stage (lymphnodes), M stage (metastases) and disease free survival (DFS) will be calculated based on an existing logistic Regression model already developed by our previous retrospective work. Additionally, a Standardisation of ITB using a well- established Software will develop an algorithm which will help to eliminate inter- observer variability of Tumor budding Counts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stages I to IV colorectal cancer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed stages I and IV colorectal cancer (CRC)\n* Age ≥ 18 years\n* Written Informed Consent\n\nExclusion Criteria:\n\n* No consent\n* \\< 18 years'}, 'identificationModule': {'nctId': 'NCT03336658', 'acronym': 'ITB', 'briefTitle': 'Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study', 'orgStudyIdInfo': {'id': '393/14'}}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of visceral surgery and transplant surgery, Berne University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Beat Schnüriger, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}