Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-29 @ 9:53 PM
Study NCT ID:
NCT05879861
Status:
UNKNOWN
Last Update Posted:
2023-05-30
First Post:
2023-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-19', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Status of frailty', 'timeFrame': '1 day', 'description': 'Status of frailty will be assessed by Fried Scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Fried Scale and its related scales were used to analyze the status and risk factors of preoperative frailty in elderly patients with colorectal cancer. R software was used to construct a risk prediction model for preoperative frailty in elderly patients with colorectal cancer, and its validity and stability were verified in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who met the diagnostic criteria of colorectal cancer in Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer 2020 Edition and underwent surgery.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. patients who met the diagnostic criteria of colorectal cancer in Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer 2020 Edition and underwent surgery;\n2. patients aged ≥60 years old ;\n3. patients who are clearly conscious, able to understand instructions, communicate normally, and complete the physical activity ability test without the assistance of others;\n4. patients who gave informed consent and volunteered to participate in the study.\n\nExclusion Criteria:\n\n1. patients with limb joint disease and lower limb pain;\n2. patients with serious heart, liver, kidney diseases could not complete the test;\n3. patients with visual impairment and hearing impairment;\n4. patients with a history of mental illness or drug dependence;\n5. taking antidepressants, levodopa/carbidopa, donepezil hydrochloride and other drugs ;\n6. patients who received preoperative radiotherapy and chemotherapy;\n7. Patients with hypothyroidism, Parkinson's disease, stroke and other diseases."}, 'identificationModule': {'nctId': 'NCT05879861', 'briefTitle': 'Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zunyi Medical College'}, 'officialTitle': 'Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer', 'orgStudyIdInfo': {'id': 'ZSKHZ Zi (2022) no. 337'}}, 'contactsLocationsModule': {'locations': [{'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongmei Zhang', 'role': 'CONTACT', 'email': 'hulizym@yeah.net', 'phone': '13885257269'}], 'facility': 'Yongmei Zhang', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}], 'centralContacts': [{'name': 'Yongmei Zhang', 'role': 'CONTACT', 'email': 'hulizym@yeah.net', 'phone': '13885257269'}], 'overallOfficials': [{'name': 'Yongmei Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zunyi Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zunyi Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Yongmei Zhang', 'investigatorAffiliation': 'Zunyi Medical College'}}}}