Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-01 @ 8:47 AM
Study NCT ID:
NCT00806650
Status:
COMPLETED
Last Update Posted:
2017-12-08
First Post:
2008-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma, and tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2008-12-10', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of primary and/or metastatic renal cell carcinoma by IMP3 autoantibody', 'timeFrame': 'Baseline', 'description': 'For the IMP3 autoantibody study, the results of IHC studies of IMP3 on the tissue sections will be used as golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P \\< 0.05 (confidence level of 95%).'}, {'measure': 'Presence of primary and/or metastatic renal cell carcinoma by miRNA/snRNA signature', 'timeFrame': 'Baseline', 'description': "For the miRNA/snRNA signature study, the patients' clinical presentation of RCC and its recurrence/metastasis will be used as the golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P \\< 0.05 (confidence level of 95%)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I renal cell cancer', 'stage II renal cell cancer', 'stage III renal cell cancer', 'stage IV renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'This research trial studies the development of a blood test for detecting anti-insulin-like growth factor II mRNA binding protein 3 (anti-IMP3) antibody and micro ribonucleic acid (microRNA) in patients with renal cell carcinoma (RCC) that has spread to other parts of the body (metastatic) or is limited to the tissue or organ where it began (localized). Anti-IMP3 is a tumor marker that can be detected in many human cancers, including RCC and is likely to be present in the serum (blood) of patients with metastatic or localized RCC. Alterations in microRNA expression has also shown to play a critical role in cancer progression and may be a promising biomarker for patients with RCC. Developing a blood test for anti-IMP3 antibody and microRNA in serum and tissue samples of patients in the laboratory may help doctors find and diagnose RCC earlier, find out how far the disease has spread, and plan effective treatment for RCC.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. To develop a blood test by monitoring the titer of IMP3 autoantibody and/or microRNA (miRNA)/small non-coding RNA (snRNA) expression in patients' serum for the early detection of RCC and its recurrence/metastasis.\n\nOUTLINE: Serum samples are collected prior to treatment and analyzed for anti-IMP3 autoantibody titer via enzyme-linked immunosorbent assay (ELISA) and total RNA via sequencing, microarray, and/or quantitative polymerase chain reaction (q-PCR). Previously collected tissue samples are analyzed for IMP3 via immunohistochemistry (IHC)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with metastatic or localized RCC', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMetastatic RCC Patients' Serum Cohort:\n\n* a. Serum samples from patients with metastatic RCC prior to surgical removal of the metastatic and/or primary lesions\n* b. Serum samples from patients with localized RCC prior to surgical removal of the lesions\n* c. Discarded donors' and patients' discarded/leftover plasma/serum samples from blood bank and other Department of Pathology laboratories\n* d. Serum samples from patients with metastatic RCC who had nephrectomies or/and RCC-related biopsies in the referring hospitals\n\nMetastatic RCC Patients' Tissue Cohort:\n\n* Formalin-fixed paraffin-embedded (FFPE) and/or frozen primary and/or metastatic RCC tissue samples from the corresponding patients serum who are included in inclusion criteria (a-b)\n* FFPE and/or frozen benign renal tissue samples which are nearby the tumor and remove during surgical procedures from the corresponding patients who are included in inclusion criteria (a-b)\n* Discarded/leftover FFPE and frozen renal tissue samples from Department of Anatomic Pathology and its Tumor Bank\n* FFPE primary and/or metastatic RCC tissue samples (unstained slides) from the corresponding patients who are included in inclusion criteria (d)\n\nExclusion Criteria:\n\nNot applicable"}, 'identificationModule': {'nctId': 'NCT00806650', 'briefTitle': 'Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Development of a Blood Test of Anti-IMP3 Autoantibody and Serum MicroRNA Signature for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential', 'orgStudyIdInfo': {'id': '07241'}, 'secondaryIdInfos': [{'id': 'CHNMC-07241'}, {'id': 'CDR0000628796', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}, {'id': 'NCI-2015-01327', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood draw for diagnosis testing', 'interventionNames': ['Genetic: gene expression analysis', 'Genetic: protein expression analysis', 'Diagnostic Test: diagnostic laboratory biomarker analysis', 'Other: immunoenzyme technique', 'Other: immunohistochemistry staining method']}], 'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC', 'description': 'Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples', 'armGroupLabels': ['Blood draw for diagnosis testing']}, {'name': 'protein expression analysis', 'type': 'GENETIC', 'description': 'Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples', 'armGroupLabels': ['Blood draw for diagnosis testing']}, {'name': 'diagnostic laboratory biomarker analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples', 'armGroupLabels': ['Blood draw for diagnosis testing']}, {'name': 'immunoenzyme technique', 'type': 'OTHER', 'description': 'Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples', 'armGroupLabels': ['Blood draw for diagnosis testing']}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'description': 'Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples', 'armGroupLabels': ['Blood draw for diagnosis testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Huiqing Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}