Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants

July 3, 2018 updated by: Wake Forest University Health Sciences

BARC: A Secreted Marker of Kidney Cancer

RATIONALE: Studying samples of blood and urine from patients with cancer and from healthy participants in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in patients with kidney cancer or cancer of the urothelium and in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine whether bone morphogenetic protein antagonist regulated in cancer (BARC) is present in urine and serum samples from patients with renal cell carcinoma or transitional cell carcinoma of the urothelium and from healthy participants and whether changes in BARC expression levels in these fluids correlate with various disease states.
  • Evaluate BARC's utility as a biomarker of kidney cancer.
  • Determine whether differences in BARC levels exist between patients with cancer vs non-cancer patients visiting the urology clinic.
  • Determine whether differences in BARC levels exist among the different types of kidney cancers.
  • Evaluate serum markers of iron metabolism and determine whether changes in BARC expression correlates with changes in these systemic iron markers.
  • Determine whether the development of an enzyme-linked immunosorbent assay to detect BARC levels as a diagnostic procedure is feasible and desirable.

OUTLINE: This is a pilot study.

Blood and urine samples are collected. Samples are evaluated by immunoblotting to detect bone morphogenetic protein antagonist regulated in cancer (BARC) and by mass spectrometry analysis to detect hepcidin levels. Serum samples are further analyzed for serum iron, ferritin, and total-iron body capacity. Histology of biopsy samples will be recorded for patients undergoing nephrectomy for renal cell carcinoma. These patients will undergo a second collection of blood and urine samples 3 months post-nephrectomy.

Study Type

Observational

Enrollment (Actual)

5

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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer 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

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Those with a diagnosis of renal cell carcinoma or a diagnosis of transitional cell carcinoma of the urothelium.

Description

Inclusion:

  • Age > 18 years

  • Meets 1 of the following criteria:

    • Diagnosis of renal cell carcinoma, meeting all of the following criteria:

      • Suitable surgical candidate
      • No clinical or pathologic T stage > T2
      • No clinical or pathologic evidence of vein and/or lymph node involvement
      • No evidence of metastatic disease as evaluated by abdominal/pelvic CT scan or MRI, chest x-ray or chest CT scan, and bone scan (if alkaline phosphatase abnormal)

    • Diagnosis of transitional cell carcinoma of the urothelium

      • Currently undergoing Bacille calmette-guérin (BCG) therapy OR has not received prior BCG therapy

    • Healthy participant (control)

      • No history of carcinoma

Exclusion:

  • Previous or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • Serious medical or psychiatric illness that would preclude study compliance
  • Current participation in a treatment related research study within the last 30 days
  • Acute illness
  • Bleeding disorder or dyscrasia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples
BARC expression levels
Correlation of changes in serum markers of iron metabolism with changes in BARC expression
Feasibility of an enzyme-linked immunosorbent assay to detect BARC levels as a diagnostic procedure

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Frank M. Torti, MD, MPH, Wake Forest University Health Sciences

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

June 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000577
  • P30CA012197 (U.S. NIH Grant/Contract)
  • CCCWFU-89A06
  • CCCWFU-IRB00000577

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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