Clinical trial NCT00900276: Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants
Official title: BARC: A Secreted Marker of Kidney Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Kidney Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Keywords: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples
measure: BARC expression levels
measure: Correlation of changes in serum markers of iron metabolism with changes in BARC expression
measure: Feasibility of an enzyme-linked immunosorbent assay to detect BARC levels as a diagnostic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Frank M. Torti, MD, MPH
role: STUDY_CHAIR
References: