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

Bladder Cancer Clinical Trial

Official title:

BARC: A Secreted Marker of Kidney Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900276
• Other study ID #: IRB00000577
• Secondary ID: P30CA012197CCCWF
• Status: Completed
• Start date: June 2006
• Est. completion date: April 2011

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• immunologic technique

• laboratory biomarker analysis

• mass spectrometry

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples
Primary	BARC expression levels
Primary	Correlation of changes in serum markers of iron metabolism with changes in BARC expression
Primary	Feasibility of an enzyme-linked immunosorbent assay to detect BARC levels as a diagnostic procedure