Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:06 PM
Study NCT ID:
NCT06006260
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Low Anterior Resection Syndrome and Balance Ability in Patients with Rectal Cancer.
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-report Questionnaire', 'timeFrame': 'Change from baseline symptom at 2 months', 'description': 'Show the specific trajectory of LAR Syndrome, psychological distress, fecal incontinence-related QoL, and balance ability based on different tumor locations in patients with rectal cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to explore the trajectory of symptom distress and balance ability in patients with rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Rectal cancer patients during therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed rectal cancer\n2. Patients already know their condition.\n3. Aged 20 years and older.\n4. Consciously communicate in Mandarin or Taiwanese.\n5. Agreed with the interview and had signed the permit.\n\nExclusion Criteria:\n\n1. Recurrent rectal cancer.\n2. KPS of patients less than 80'}, 'identificationModule': {'nctId': 'NCT06006260', 'briefTitle': 'Changes of Low Anterior Resection Syndrome and Balance Ability in Patients with Rectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Changes of Low Anterior Resection Syndrome, Balance Ability, and Quality of Life in Patients with Newly Diagnosed Rectal Cancer.', 'orgStudyIdInfo': {'id': '20220197B0'}}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan', 'state': 'Kwei-Shan Dist.', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yun-Jen Chou, PhD', 'role': 'CONTACT', 'email': 'yjchou@mail.cgu.edu.tw', 'phone': '+886-3-2118800', 'phoneExt': '3512'}], 'facility': 'Chung Gung University', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'Yun-Jen Chou, PhD', 'role': 'CONTACT', 'email': 'yjchou@mail.cgu.edu.tw', 'phone': '+886-3-2118800', 'phoneExt': '3512'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}