Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants
NCT ID: NCT00900276
Last Updated: 2018-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
5 participants
OBSERVATIONAL
2006-06-30
2011-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This laboratory study is looking at biomarkers in patients with kidney cancer or cancer of the urothelium and in healthy participants.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer
NCT00899860
A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma
NCT01063998
Biomarkers in Urine Samples From Patients With Wilms Tumor
NCT01550393
NANOTECH RCC Biomarkers
NCT02923284
Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors
NCT01004783
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
immunologic technique
laboratory biomarker analysis
mass spectrometry
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
120 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frank M. Torti, MD, MPH
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCCWFU-89A06
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-IRB00000577
Identifier Type: -
Identifier Source: secondary_id
IRB00000577
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.