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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00806650
First received: December 10, 2008
Last updated: August 19, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention
Kidney Cancer
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: diagnostic laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Presence of primary and/or metastatic renal cell carcinoma [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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. 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%).


Estimated Enrollment: 230
Study Start Date: June 2008
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Other: 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

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 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806650

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: City of Hope Medical Center    800-826-4673      
Principal Investigator: Huiqing Wu, MD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Huiqing Wu, MD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00806650     History of Changes
Other Study ID Numbers: 07241, CHNMC-07241, CDR0000628796, NCI-2015-01327
Study First Received: December 10, 2008
Last Updated: August 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Autoantibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 31, 2015