Urine Proteome of Surgical Patients and Healthy Volunteers
UP
1 other identifier
observational
664
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 20, 2012
CompletedFirst Posted
Study publicly available on registry
February 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJanuary 7, 2019
January 1, 2019
4.4 years
February 20, 2012
January 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
5 years
Study Arms (7)
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients on dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry Morrissey, PhD
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2012
First Posted
February 24, 2012
Study Start
February 1, 2012
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
January 7, 2019
Record last verified: 2019-01