NANOTECH RCC Biomarkers

May 5, 2020 updated by: Washington University School of Medicine

Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility

The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

407

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 St Louis 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 that are 18 years of age and older and undergoing planned surgical procedure for removal of an imaged renal mass will be consented in the Center for Preoperative Assessment and Planning (CPAP), the holding area on the day of surgery, and the holding area of radiology. A urine sample will be collected from subject following informed consent. Additionally, discarded urine samples will be collected from the BJH Chemistry Labs from patients admitted for surgery for non-kidney cancer as a comparator group.

Description

Inclusion Criteria:

Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total),

Exclusion Criteria:

Age <18 years and prisoners.

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
Imaged renal mass cohort
Subjects undergoing surgery for an kidney tumor identified radiologically.
control cohort
Subjects undergoing surgery for any kind of cancer other than kidney.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine AQP1
Time Frame: 28 days
Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
28 days
PLIN2 concentration
Time Frame: 28 days
Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
28 days

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jeremiah Morrissey, PhD, Washington University School of Medicine

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

August 1, 2016

Primary Completion (Actual)

January 2, 2020

Study Completion (Actual)

January 2, 2020

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201601082
  • 5R01CA141521 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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