Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04422002
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2020-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survival Analysis of Frail Patients With Localised Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000073496', 'term': 'Frailty'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Surgery', 'Frailty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment', 'detailedDescription': 'Patients with localized colorectal cancer will be visited by a colorectal surgeon who will explain the disease and the surgical treatment. In this visit the patient will be screened for frailty and asked for informed consent. Patients who meet the eligibility criteria will be sent to the internal medicine consultant to frailty evaluation, risk assessment and counselling in order to help patient decision process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with a recent diagnostic of localised colorectal cancer and a positive frailty screening', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Localised colorectal cancer\n* Positive frailty screening\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04422002', 'briefTitle': 'Survival Analysis of Frail Patients With Localised Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Survival Analysis of Frail Patients With Localised Colorectal Cancer: Multicentre Observational Study, Comparing Surgical vs Palliative Treatment', 'orgStudyIdInfo': {'id': 'CSPT-ONCOFRAGIL.2020-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical treatment'}, {'label': 'Palliative treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporacio Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ana Granados-Maturano', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}