SurgeryNCT00851994
Urine Proteome of Patients Having Surgery
An observational study of Surgery, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators are measuring novel proteins in the urine of patients having surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Surgery
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having surgery.
Who may be able to join
- Patients > 18 years of age
- Undergoing surgery
Who cannot join
- No formal exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urine Proteome of Patients Undergoing Surgery
The investigators are measuring novel proteins in the urine of patients having surgery.
- Conditions
- Surgery
- Keywords
- Patients having surgery
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 |
|---|---|---|
| 1 | Patients having surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urine proteins after surgery.
Measured: Pre-op, intraoperative, post operatively (1-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 274 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
- NCT00851994
- Sponsor's protocol ID
- 201103022
- Status last verified
- Oct 2016
- First submitted
- 25 Feb 2009
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
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 31668633Morrissey JJ, Mobley J, Figenshau RS, Vetter J, Bhayani S, Kharasch ED. Urine aquaporin 1 and perilipin 2 differentiate renal carcinomas from other imaged renal masses and bladder and prostate cancer. Mayo Clin Proc. 2015 Jan;90(1):35-42. doi: 10.1016/j.mayocp.2014.10.005.
PubMed 25572193Morrissey JJ, Kharasch ED. The specificity of urinary aquaporin 1 and perilipin 2 to screen for renal cell carcinoma. J Urol. 2013 May;189(5):1913-20. doi: 10.1016/j.juro.2012.11.034. Epub 2012 Nov 12.
PubMed 23154208Morrissey JJ, London AN, Lambert MC, Kharasch ED. Sensitivity and specificity of urinary neutrophil gelatinase-associated lipocalin and kidney injury molecule-1 for the diagnosis of renal cell carcinoma. Am J Nephrol. 2011;34(5):391-8. doi: 10.1159/000330851. Epub 2011 Sep 7.
PubMed 21912102Morrissey JJ, London AN, Luo J, Kharasch ED. Urinary biomarkers for the early diagnosis of kidney cancer. Mayo Clin Proc. 2010 May;85(5):413-21. doi: 10.4065/mcp.2009.0709. Epub 2010 Apr 7.
PubMed 20375178
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Proteome of Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT00851994
- Acronym / sponsor ID
- 201103022
- Conditions
- Surgery
- Keywords
- Patients having surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Feb 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.
The investigators are measuring novel proteins in the urine of patients having surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients having surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having surgery.
Key inclusion criteria (2 listed)
- Patients > 18 years of age
- Undergoing surgery
Key exclusion criteria (1 listed)
- No formal exclusion criteria
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
Changes in urine proteins after surgery.
Time frame: Pre-op, intraoperative, post operatively (1-6 months)
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 1 Nov 2016.
- 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.
- Derived from this study: PubMed 25572193Morrissey JJ, Mobley J, Figenshau RS, Vetter J, Bhayani S, Kharasch ED. Urine aquaporin 1 and perilipin 2 differentiate renal carcinomas from other imaged renal masses and bladder and prostate cancer. Mayo Clin Proc. 2015 Jan;90(1):35-42. doi: 10.1016/j.mayocp.2014.10.005.
- Derived from this study: PubMed 23154208Morrissey JJ, Kharasch ED. The specificity of urinary aquaporin 1 and perilipin 2 to screen for renal cell carcinoma. J Urol. 2013 May;189(5):1913-20. doi: 10.1016/j.juro.2012.11.034. Epub 2012 Nov 12.
- Derived from this study: PubMed 21912102Morrissey JJ, London AN, Lambert MC, Kharasch ED. Sensitivity and specificity of urinary neutrophil gelatinase-associated lipocalin and kidney injury molecule-1 for the diagnosis of renal cell carcinoma. Am J Nephrol. 2011;34(5):391-8. doi: 10.1159/000330851. Epub 2011 Sep 7.
- Derived from this study: PubMed 20375178Morrissey JJ, London AN, Luo J, Kharasch ED. Urinary biomarkers for the early diagnosis of kidney cancer. Mayo Clin Proc. 2010 May;85(5):413-21. doi: 10.4065/mcp.2009.0709. Epub 2010 Apr 7.
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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 Surgery, 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 2 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 1 Nov 2016. 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?
Changes in urine proteins after surgery. (time frame: Pre-op, intraoperative, post operatively (1-6 months)). 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 NCT00851994, which also lists 5 linked publications.
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 1 Nov 2016.