Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants
BARC: A Secreted Marker of Kidney Cancer
4 other identifiers
observational
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJuly 5, 2018
July 1, 2018
4.8 years
May 9, 2009
July 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples
BARC expression levels
Correlation of changes in serum markers of iron metabolism with changes in BARC expression
Feasibility of an enzyme-linked immunosorbent assay to detect BARC levels as a diagnostic procedure
Interventions
Eligibility Criteria
Those with a diagnosis of renal cell carcinoma or a diagnosis of transitional cell carcinoma of the urothelium.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frank M. Torti, MD, MPH
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
June 1, 2006
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
July 5, 2018
Record last verified: 2018-07