Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:57 AM
Study NCT ID:
NCT07489833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic Pathways and Traditional Chinese Medicine Body Constitution in Cancer-related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The retained samples consist of plasma processed from whole blood. The cellular components (buffy coat and red blood cells) are discarded, and only the acellular plasma fraction is retained for metabolomic analysis related to fatigue mechanisms.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-report Questionnaire', 'timeFrame': 'Change from baseline to 3 months after surgery.', 'description': 'The structure includes the Fatigue Symptom Inventory, and the Body Constitution Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to integrate insights from metabolomics and TCMBC to identify biomarkers and physiological pathways associated with CRF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed with stage I to III CRC and scheduled for surgical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) patients aged 18 years or older, (2) diagnosed with stage I to III CRC and scheduled for surgical treatment, (3) cognitively intact and able to communicate in either Mandarin or Taiwanese, and (4) willing to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* (1) patients diagnosed with stage IV colorectal cancer, and (2) patients with recurrent colorectal cancer or other concurrent cancers.'}, 'identificationModule': {'nctId': 'NCT07489833', 'briefTitle': 'Metabolomic Pathways and Traditional Chinese Medicine Body Constitution in Cancer-related Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Exploration of the Relationship Between Metabolomic Pathways and Traditional Chinese Medicine Body Constitution in Cancer-related Fatigue in Patients With Colorectal Cancer', 'orgStudyIdInfo': {'id': '202402033B0'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yun-Jen Chou, PhD', 'role': 'CONTACT', 'email': 'yjchou@mail.cgu.edu.tw', 'phone': '886-3-2118800', 'phoneExt': '3512'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}