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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00900276

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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

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 Design

Study Type:

Observational

Actual Enrollment :

5 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

BARC: A Secreted Marker of Kidney Cancer

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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