CompletedNot Applicable

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

United States5 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00900276

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-04

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