Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants
This study has been completed.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00900276
First received: May 9, 2009
Last updated: April 17, 2012
Last verified: April 2012
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | BARC: A Secreted Marker of Kidney Cancer |
Resource links provided by NLM:
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples [ Designated as safety issue: No ]
- BARC expression levels [ Designated as safety issue: No ]
- Correlation of changes in serum markers of iron metabolism with changes in BARC expression [ Designated as safety issue: No ]
- Feasibility of an enzyme-linked immunosorbent assay to detect BARC levels as a diagnostic procedure [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900276
Locations
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
| Study Chair: | Frank M. Torti, MD, MPH | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Suzy Torti, Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00900276 History of Changes |
| Other Study ID Numbers: | CDR0000550059, P30CA012197, CCCWFU-89A06, CCCWFU-IRB00000577 |
| Study First Received: | May 9, 2009 |
| Last Updated: | April 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
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 |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms |
Urinary Bladder Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Urethral Diseases Ureteral Diseases |
ClinicalTrials.gov processed this record on May 16, 2013