Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT03252834
Status:
TERMINATED
Last Update Posted:
2025-07-14
First Post:
2017-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of thermal pain threshold', 'timeFrame': 'before chemotherapy & 3, 6, and 9 months after chemotherapy', 'description': 'The threshold of detecting heat-induced pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Abnormal Thermal Sensation']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single arm, single center study evaluating the use of a 4-gene panel to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial and ovarian cancer patients receiving post-operative chemotherapy with Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July\\~ 2019 June. Blood sample will be collected before chemotherapy to analyze the genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D \\& CIPN20). The primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Colorectal, endometrial, or ovarian cancer patients who are scheduled to receive post-operative adjuvant chemotherapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years old\n* Pathological stage I\\~IV for ovarian cancer, stage II\\~IV for endometrial cancer, or stage III for colorectal cancer.\n* Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer.\n* Patient willing to provide blood sample for research purposes.\n* Ability of the patient to provide informed consent.\n\nExclusion Criteria:\n\n* Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids.\n* Receiving chemotherapy within 6 months.\n* A family history of a genetic or familial neuropathy\n* Poor compliance'}, 'identificationModule': {'nctId': 'NCT03252834', 'briefTitle': 'Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients', 'orgStudyIdInfo': {'id': 'B-ER-106-120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with endometrial or ovarian cancer', 'interventionNames': ['Diagnostic Test: Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI']}, {'label': 'Patients with colorectal cancer', 'interventionNames': ['Diagnostic Test: Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI']}], 'interventions': [{'name': 'Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.', 'armGroupLabels': ['Patients with colorectal cancer', 'Patients with endometrial or ovarian cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean for Research', 'investigatorFullName': 'Meng-Ru Shen', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}