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BARC: A Secreted Marker of Kidney Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Kidney Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

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Trial Information

BARC: A Secreted Marker of Kidney Cancer


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 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples

Safety Issue:

No

Principal Investigator

Frank M. Torti, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000550059

NCT ID:

NCT00900276

Start Date:

June 2006

Completion Date:

April 2011

Related Keywords:

  • Bladder Cancer
  • Kidney Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Ureteral Neoplasms

Name

Location
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096