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Trial record 3 of 4 for:    AQP1

NANOTECH RCC Biomarkers

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ClinicalTrials.gov Identifier: NCT02923284
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

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
Renal Cell Carcinoma Renal Cell Cancer

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility
Study Start Date : August 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Urine AQP1 [ Time Frame: 28 days ]
    Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.

  2. PLIN2 concentration [ Time Frame: 28 days ]
    Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.


Biospecimen Retention:   Samples Without DNA
Urine samples will be retained with a study-specific code that links the samples to data collected from the electronic medical record.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923284


Contacts
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Contact: Jeremiah Morrissey, PhD (314) 454-7464 morrissj@anest.wustl.edu

Locations
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United States, Missouri
Washington University St Louis School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Cynthia Tang, BS    314-747-1690    tangc@anest.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeremiah Morrissey, PhD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02923284     History of Changes
Other Study ID Numbers: 201601082
5R01CA141521 ( U.S. NIH Grant/Contract )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases