Urine Proteome of Surgical Patients and Healthy Volunteers (UP)

January 4, 2019 updated by: Washington University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

664

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients on dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (Estimate)

February 24, 2012

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201202051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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