Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT04524650
Status:
UNKNOWN
Last Update Posted:
2020-08-28
First Post:
2020-08-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Diagnosis of Oxaliplatin-induced Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D013163', 'term': 'Splenomegaly'}], '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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the severity of portal hypertension', 'timeFrame': '1 day (the same time as diagnosis)', 'description': 'High portal pressure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['portal hypertension', 'splenomegaly', 'colorectal carcinoma', 'oxaliplatin', 'hepatotoxicity'], 'conditions': ['Gastroesophageal Varices', 'Colorectal Cancer', 'Received Oxaliplatin-based Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '32380558', 'type': 'RESULT', 'citation': 'Huang X, Li F, Wang L, Xiao M, Ni L, Jiang S, Ji Y, Zhang C, Zhang W, Wang J, Chen S. Endoscopic treatment of gastroesophageal variceal bleeding after oxaliplatin-based chemotherapy in patients with colorectal cancer. Endoscopy. 2020 Sep;52(9):727-735. doi: 10.1055/a-1157-8611. Epub 2020 May 7.'}, {'pmid': '17075116', 'type': 'RESULT', 'citation': 'Aloia T, Sebagh M, Plasse M, Karam V, Levi F, Giacchetti S, Azoulay D, Bismuth H, Castaing D, Adam R. Liver histology and surgical outcomes after preoperative chemotherapy with fluorouracil plus oxaliplatin in colorectal cancer liver metastases. J Clin Oncol. 2006 Nov 1;24(31):4983-90. doi: 10.1200/JCO.2006.05.8156.'}]}, 'descriptionModule': {'briefSummary': 'Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, the investigators aim to evaluate the values of potential biomarkers in diagnosing patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had a history of colorectal cancer and received oxaliplatin-based chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 18-75\n* Had a history of oxaliplatin-based chemotherapy for the treatment of colorectal cancer surgery;\n\nExclusion Criteria:\n\n* Combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.\n* With colorectal cancer required further anti-tumor treatment'}, 'identificationModule': {'nctId': 'NCT04524650', 'briefTitle': 'Early Diagnosis of Oxaliplatin-induced Portal Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Construction and Evaluation of the Early Identification for Oxaliplatin Induced Portal Hypertension', 'orgStudyIdInfo': {'id': 'PLAEGV-DIA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stage 0', 'description': 'without liver function injury or splenomegaly', 'interventionNames': ['Diagnostic Test: the level of vWF']}, {'label': 'stage 1', 'description': 'occurrence of liver function injury (ALT or AST \\> 2 ULN (upper limit of normal)', 'interventionNames': ['Diagnostic Test: the level of vWF']}, {'label': 'stage 2', 'description': 'occurrence of splenomegaly or reduced platelet count (\\<150 X10\\^9/L)', 'interventionNames': ['Diagnostic Test: the level of vWF']}, {'label': 'stage 3', 'description': 'occurrence of portal hypertension and/or gastroesophageal varices', 'interventionNames': ['Diagnostic Test: the level of vWF']}], 'interventions': [{'name': 'the level of vWF', 'type': 'DIAGNOSTIC_TEST', 'description': 'the peripheral level of vWF', 'armGroupLabels': ['stage 0', 'stage 1', 'stage 2', 'stage 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Gastroenterology and Hepatology', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaoquan HUANG', 'role': 'CONTACT', 'email': 'huang.xiaoquan@zs-hospital.sh.cn', 'phone': '008618801733835'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shiyao Chen', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}