NCT00851994

Brief Summary

The investigators are measuring novel proteins in the urine of patients having surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

8.1 years

First QC Date

February 25, 2009

Last Update Submit

October 31, 2016

Conditions

Surgery

Keywords

Patients having surgery

Outcome Measures

Primary Outcomes (1)

  • Changes in urine proteins after surgery.

    Pre-op, intraoperative, post operatively (1-6 months)

Study Arms (1)

1

Patients having surgery

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having surgery.

You may qualify if:

  • Patients \> 18 years of age
  • Undergoing surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

  • 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.

    PMID: 31668633DERIVED

  • Morrissey 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.

    PMID: 25572193DERIVED

  • Morrissey 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.

    PMID: 23154208DERIVED

  • Morrissey 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.

    PMID: 21912102DERIVED

  • Morrissey 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.

    PMID: 20375178DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We are collecting urine and blood samples.

Study Officials

  • Jerry Morrissey, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

July 1, 2008

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)