Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT00984035
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2009-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Cisplatin-Related Kidney Toxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D004247', 'term': 'DNA'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine Blood Serum/Plasma Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2009-09-22', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in urine biomarker (NGAL) after cisplatin', 'timeFrame': 'while on drug and up to 35 days after end of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in blood and urine cystatin C', 'timeFrame': 'while on drug and up to 35 days after end of treatment'}, {'measure': 'Change in blood NGAL while receiving cisplatin', 'timeFrame': 'while on drug and up to 35 days after end of treatment'}, {'measure': 'Genetic markers of kidney toxicity', 'timeFrame': 'while on drug and up to 35 days after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify novel biomarkers of kidney injury in patients receiving cisplatin.\n\nThis study will also collect DNA for future analysis.', 'detailedDescription': 'This study will look for novel biomarkers of kidney injury in patients receiving cisplatin in patients currently receiving cisplatin.\n\nDNA will be collected both prospectively and retrospectively (from patients that have previously received cisplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving anti-cancer treatment with cisplatin (or previously treated with cisplatin) at a participating academic medical center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Prospective Analysis Group\n\nInclusion Criteria:\n\n* Patients about to receive intravenous cisplatin for the first time as part of cancer chemotherapy.\n* Aged 18 years and older.\n* Ability to understand and willingness to sign a written consent document.\n* Patients may be receiving cisplatin in combination with other chemotherapeutic agents.\n* Patients may be receiving cisplatin in the context of another clinical trial.\n\nExclusion Criteria:\n\n* Prior receipt of cisplatin.\n* Patients on dialysis or other renal replacement therapy prior to starting cisplatin.\n* Uncontrolled hypo- or hyperthyroidism (patients on chronic stable doses of thyroid replacement medication are eligible).\n\nRetrospective Analysis Group\n\nInclusion Criteria:\n\n* Patients that have previously received intravenous cisplatin as part of cancer chemotherapy.\n* Aged 18 years and older.\n* Ability to understand and willingness to sign a written consent document.\n* Patients that received cisplatin in combination with other chemotherapeutic agents are eligible.\n* Patients that received cisplatin in the context of a clinical trial are eligible.\n\nExclusion Criteria:\n\n* Unable or unwilling to submit to a one-time blood draw.'}, 'identificationModule': {'nctId': 'NCT00984035', 'briefTitle': 'Investigation of Cisplatin-Related Kidney Toxicity', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity', 'orgStudyIdInfo': {'id': '09-135-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospecitive Analysis', 'description': 'Patients currently receiving cisplatin as treatment for their cancer.', 'interventionNames': ['Other: urine samples (biomarkers)', 'Other: blood samples (biomarkers)', 'Other: blood sample (DNA)']}, {'label': 'Restrospective Analysis', 'description': 'Patients that have previously received cisplatin as treatment for their cancer.', 'interventionNames': ['Other: blood sample (DNA)']}], 'interventions': [{'name': 'urine samples (biomarkers)', 'type': 'OTHER', 'description': 'Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.', 'armGroupLabels': ['Prospecitive Analysis']}, {'name': 'blood samples (biomarkers)', 'type': 'OTHER', 'description': 'blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.', 'armGroupLabels': ['Prospecitive Analysis']}, {'name': 'blood sample (DNA)', 'type': 'OTHER', 'description': 'Blood sample collected for DNA analysis at anytime while on-study.', 'armGroupLabels': ['Prospecitive Analysis', 'Restrospective Analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': "Peter H O'Donnell, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society of Clinical Oncology', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}