Bladder CancerNCT00900276
Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants
An observational study of Bladder Cancer and Kidney Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Kidney Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
- What is being tested?
- immunologic technique, laboratory biomarker analysis and mass spectrometry
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those with a diagnosis of renal cell carcinoma or a diagnosis of transitional cell carcinoma of the urothelium.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: BARC: A Secreted Marker of Kidney Cancer
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.
Read the detailed 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.
- Conditions
- Bladder Cancer, Kidney Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
- Being tested
- immunologic technique, laboratory biomarker analysis, mass spectrometry
- Keywords
- 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
- Medical subject headings
- Urinary Bladder Neoplasms, Kidney Neoplasms, Urethral Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunologic techniqueOther
laboratory biomarker analysisOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 2006
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frank M. Torti, MD, MPH, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900276
- Sponsor's protocol ID
- IRB00000577
- Other IDs
- P30CA012197, CCCWFU-89A06, CCCWFU-IRB00000577
- Status last verified
- Jul 2018
- First submitted
- 9 May 2009
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BARC: A Secreted Marker of Kidney Cancer
- ClinicalTrials.gov ID
- NCT00900276
- Acronym / sponsor ID
- IRB00000577
- Conditions
- Bladder Cancer, Kidney Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those with a diagnosis of renal cell carcinoma or a diagnosis of transitional cell carcinoma of the urothelium.
Key inclusion criteria (11 listed)
- Age > 18 years
- Meets 1 of the following criteria:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
| mass spectrometry | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank M. Torti, MD, MPH study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Kidney Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of bone morphogenetic protein antagonist regulated in cancer (BARC) in urine and serum samples. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.