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

December 10, 2008
August 19, 2015
June 2008
November 2016   (final data collection date for primary outcome measure)
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%).
Presence of metastatic renal cell carcinoma [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00806650 on ClinicalTrials.gov Archive Site
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Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Kidney Cancer
  • 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
Experimental: Blood draw for diagnosis testing
Interventions:
  • Genetic: gene expression analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunoenzyme technique
  • Other: immunohistochemistry staining method
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
Not Provided
November 2016   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
United States
 
NCT00806650
07241, CHNMC-07241, CDR0000628796, NCI-2015-01327
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Huiqing Wu, MD City of Hope Medical Center
City of Hope Medical Center
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP