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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

Tracking Information
First Submitted Date September 7, 2016
First Posted Date October 4, 2016
Last Update Posted Date September 23, 2019
Study Start Date August 2016
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2016)
  • Urine AQP1 [ Time Frame: 28 days ]
    Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
  • PLIN2 concentration [ Time Frame: 28 days ]
    Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02923284 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NANOTECH RCC Biomarkers
Official Title Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine samples will be retained with a study-specific code that links the samples to data collected from the electronic medical record.
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.
Condition
  • Renal Cell Carcinoma
  • Renal Cell Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 3, 2016)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jeremiah Morrissey, PhD (314) 454-7464 morrissj@anest.wustl.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02923284
Other Study ID Numbers 201601082
5R01CA141521 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeremiah Morrissey, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2019