Renal Cell CancerUPNCT01538823
Urine Proteome of Surgical Patients and Healthy Volunteers
An observational study of Renal Cell Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective, screening techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer
- How many people
- 664 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to have full or partial kidney removal surgery (possibly because of kidney cancer). Patients scheduled to have a procedure because you may have bladder or prostate cancer. Patients scheduled to have some other type of surgery (non-urological). Healthy volunteers
Who may be able to join
- 18 years and older
- Planned procedure with presumptive diagnosis of RCC, bladder or prostate cancer OR control patient undergoing non-urological surgery OR normal healthy volunteer OR post surgical patient with a diagnosis of RCC and under surveillance for reoccurrence of RCC or treatment of metastatic RCC
- Signed, informed consent
Who cannot join
- Patients on dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Urine Proteome of Surgical Patients and Healthy Volunteers.
The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective, screening techniques.
- Conditions
- Renal Cell Cancer
- Keywords
- Surgery, Renal Cell Cancer
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Enrollment of surgical patients at Barnes Jewish Hospital (BJH) with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy. | |
| Group 2 | Surgical patients at BJH with non urological cancers | |
| Group 3 | Surgical patients at BJH with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy | |
| Group 4 | Surgical patients at BJH with non urological cancers | |
| Group 5 | Healthy volunteers with no history of cancer or renal disease | |
| Group 6 | Patients at BJH/Washington University School of Medicine under post procedure surveillance for RCC recurrence and patients under treatment for metastatic disease. | |
| Group 7 | Patients with a presumptive diagnosis of bladder cancer or prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of novel bio markers
The overall objective of our study is to find and evaluate additional novel biomarkers, predictive of disease, that are present and measurable in whole urine of patients undergoing surgery for renal cancer.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerry Morrissey, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538823
- Sponsor's protocol ID
- 201202051
- Acronym
- UP
- Status last verified
- Jan 2019
- First submitted
- 20 Feb 2012
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu R, Gupta R, Wang Z, Wang C, Sun H, Singamaneni S, Kharasch ED, Morrissey JJ. Bioplasmonic paper-based assay for perilipin-2 non-invasively detects renal cancer. Kidney Int. 2019 Dec;96(6):1417-1421. doi: 10.1016/j.kint.2019.08.020. Epub 2019 Sep 3.
PubMed 31668633
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Proteome of Surgical Patients and Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01538823
- Acronym / sponsor ID
- UP / 201202051
- Conditions
- Renal Cell Cancer
- Keywords
- Surgery, Renal Cell Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Feb 2012 (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.
The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective, screening techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Enrollment of surgical patients at Barnes Jewish Hospital (BJH) with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy. |
| Group 2 | – | –Surgical patients at BJH with non urological cancers |
| Group 3 | – | –Surgical patients at BJH with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy |
| Group 4 | – | –Surgical patients at BJH with non urological cancers |
| Group 5 | – | –Healthy volunteers with no history of cancer or renal disease |
| Group 6 | – | –Patients at BJH/Washington University School of Medicine under post procedure surveillance for RCC recurrence and patients under treatment for metastatic disease. |
| Group 7 | – | –Patients with a presumptive diagnosis of bladder cancer or prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to have full or partial kidney removal surgery (possibly because of kidney cancer). Patients scheduled to have a procedure because you may have bladder or prostate cancer. Patients scheduled to have some other type of surgery (non-urological). Healthy volunteers
Key inclusion criteria (3 listed)
- 18 years and older
- Planned procedure with presumptive diagnosis of RCC, bladder or prostate cancer OR control patient undergoing non-urological surgery OR normal healthy volunteer OR post surgical patient with a diagnosis of RCC and under surveillance for reoccurrence of RCC or treatment of metastatic RCC
- Signed, informed consent
Key exclusion criteria (1 listed)
- Patients on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of novel bio markers
Time frame: 5 years
The overall objective of our study is to find and evaluate additional novel biomarkers, predictive of disease, that are present and measurable in whole urine of patients undergoing surgery for renal cancer.
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 7 Jan 2019.
- Derived from this study: PubMed 31668633Hu R, Gupta R, Wang Z, Wang C, Sun H, Singamaneni S, Kharasch ED, Morrissey JJ. Bioplasmonic paper-based assay for perilipin-2 non-invasively detects renal cancer. Kidney Int. 2019 Dec;96(6):1417-1421. doi: 10.1016/j.kint.2019.08.020. Epub 2019 Sep 3.
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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.
Jerry Morrissey, PhD principal investigator
Washington University School of Medicine
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 Renal Cell Cancer, run by Washington University School of Medicine 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 3 inclusion and 1 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 7 Jan 2019. 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?
evaluation of novel bio markers (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538823, which also lists 1 linked publication.
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 7 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.