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.

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