Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer

Completed

• Conditions: Kidney Cancer
• Interventions: Genetic: gene expression analysis; Genetic: protein expression analysis; Diagnostic Test: diagnostic laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method

• Registration Number: NCT00806650
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

I. 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.

OUTLINE: 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).

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-15
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Metastatic RCC Patients' Serum Cohort:

• a. Serum samples from patients with metastatic RCC prior to surgical removal of the metastatic and/or primary lesions
• b. Serum samples from patients with localized RCC prior to surgical removal of the lesions
• c. Discarded donors' and patients' discarded/leftover plasma/serum samples from blood bank and other Department of Pathology laboratories
• d. Serum samples from patients with metastatic RCC who had nephrectomies or/and RCC-related biopsies in the referring hospitals

Metastatic RCC Patients' Tissue Cohort:

• 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)
• 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)
• Discarded/leftover FFPE and frozen renal tissue samples from Department of Anatomic Pathology and its Tumor Bank
• FFPE primary and/or metastatic RCC tissue samples (unstained slides) from the corresponding patients who are included in inclusion criteria (d)

Exclusion Criteria

Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood draw for diagnosis testing	protein expression analysis	-
Blood draw for diagnosis testing	diagnostic laboratory biomarker analysis	-
Blood draw for diagnosis testing	immunohistochemistry staining method	-
Blood draw for diagnosis testing	gene expression analysis	-
Blood draw for diagnosis testing	immunoenzyme technique	-

Primary Outcome Measures

Name	Time	Method
Presence of primary and/or metastatic renal cell carcinoma by IMP3 autoantibody	Baseline	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%).
Presence of primary and/or metastatic renal cell carcinoma by miRNA/snRNA signature	Baseline	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%).

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States