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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: BARC: A Secreted Marker of Kidney Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: June 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  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: NCT00900276

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Frank M. Torti, MD, MPH Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Suzy Torti, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00900276     History of Changes
Other Study ID Numbers: CDR0000550059, P30CA012197, CCCWFU-89A06, CCCWFU-IRB00000577
Study First Received: May 9, 2009
Last Updated: April 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
localized transitional cell cancer of the renal pelvis and ureter
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
transitional cell carcinoma of the bladder
stage I renal cell cancer
stage II renal cell cancer
recurrent renal cell cancer
recurrent bladder cancer
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
anterior urethral cancer
posterior urethral cancer
recurrent urethral cancer
urethral cancer associated with invasive bladder cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urinary Bladder Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ureteral Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014