Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT04788368
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological clear margins', 'timeFrame': '1-2 months after surgery', 'description': 'Pathological examination of the specimen showing free margins'}, {'measure': 'Complications after surgery', 'timeFrame': '90 days after surgery', 'description': 'Complications graded using the Clavien Dindo classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rectal cancer treated with a local resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rectal cancer resected by local resection\n\nExclusion Criteria:\n\n* All other types of resection or treatment for rectal cancer'}, 'identificationModule': {'nctId': 'NCT04788368', 'acronym': 'TRECA', 'briefTitle': 'TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland', 'orgStudyIdInfo': {'id': 'TRECA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with TEM - transanala microsurgery', 'description': 'Early rectal cancer treated with TEM - full thickness resection', 'interventionNames': ['Procedure: Surgical resection']}, {'label': 'Patients treated with ESD', 'description': 'Early rectal cancer treated with the endoscopic treatment ESD - endoscopic submucosal resection', 'interventionNames': ['Procedure: Surgical resection']}, {'label': 'Patients treated with EMR', 'description': 'Early rectal cancer treated with the endoscopic treatment EMR - endoscopic mucosal resection', 'interventionNames': ['Procedure: Surgical resection']}], 'interventions': [{'name': 'Surgical resection', 'type': 'PROCEDURE', 'description': 'Surgical resection with either of the above mentioned techniques', 'armGroupLabels': ['Patients treated with EMR', 'Patients treated with ESD', 'Patients treated with TEM - transanala microsurgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eva Angenete', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}