Clincosm LogoSign in Get a demo

NANOTECH RCC Biomarkers

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02923284
Collaborator
National Cancer Institute (NCI) (NIH)
407
Enrollment
1
Location
41
Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    407 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility
    Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Jan 2, 2020
    Actual Study Completion Date :
    Jan 2, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Urine AQP1 [28 days]

      Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.

    2. PLIN2 concentration [28 days]

      Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University St Louis School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02923284
    Other Study ID Numbers:
    • 201601082
    • 5R01CA141521
    First Posted:
    Oct 4, 2016
    Last Update Posted:
    May 7, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of May 7, 2020