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

December 6, 2017 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with metastatic or localized RCC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blood draw for diagnosis testing
Genetic: gene expression analysis
Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
Genetic: protein expression analysis
Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
Diagnostic test: diagnostic laboratory biomarker analysis
Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
Other: immunoenzyme technique
Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
Other: immunohistochemistry staining method
Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of primary and/or metastatic renal cell carcinoma by IMP3 autoantibody
Time Frame: 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%).
Baseline
Presence of primary and/or metastatic renal cell carcinoma by miRNA/snRNA signature
Time Frame: 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%).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Huiqing Wu, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

November 15, 2017

Study Completion (ACTUAL)

November 15, 2017

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (ESTIMATE)

December 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07241
  • CHNMC-07241
  • CDR0000628796 (REGISTRY: NCI PDQ)
  • NCI-2015-01327 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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