NANOTECH RCC Biomarkers

Renal Cell Carcinoma Clinical Trial

Official title:

Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923284
• Other study ID #: 201601082
• Secondary ID: 5R01CA141521
• Status: Completed
• Start date: August 2016
• Est. completion date: January 2, 2020

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer
• Renal Cell Carcinoma

Locations

Country	Name	City	State
United States	Washington University St Louis School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine AQP1	Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.	28 days
Primary	PLIN2 concentration	Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.	28 days