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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00900276
First received: May 9, 2009
Last updated: April 17, 2012
Last verified: April 2012

May 9, 2009
April 17, 2012
June 2006
April 2011   (final data collection date for primary outcome measure)
  • Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples [ Designated as safety issue: No ]
  • BARC expression levels [ Designated as safety issue: No ]
  • Correlation of changes in serum markers of iron metabolism with changes in BARC expression [ Designated as safety issue: No ]
  • Feasibility of an enzyme-linked immunosorbent assay to detect BARC levels as a diagnostic procedure [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00900276 on ClinicalTrials.gov Archive Site
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Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants
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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

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

  • Bladder Cancer
  • Kidney Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
  • Other: mass spectrometry
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00900276
CDR0000550059, P30CA012197, CCCWFU-89A06, CCCWFU-IRB00000577
Yes
Suzy Torti, Wake Forest University Health Sciences
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Frank M. Torti, MD, MPH Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
April 2012

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