An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy

Who is this study for? Patients undergoing surgical resection and/or biopsy
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to understand the metabolism of cancers involving the kidney, including renal cell carcinomas and urothelial cell carcinomas, and how kidney cancers use different types of fuel to support tumor growth. This study uses specially labeled nutrient tracers of compounds normally found circulating in the blood. The nutrients (glucose, fructose, glutamine, acetate, and lactate) are also found in common foods. A nutrient tracer will be given to the participants through an intravenous (IV) catheter during surgery or biopsy, and blood will be collected every 30 minutes during the infusion to monitor safety parameters and the nutrient tracers. The investigators will collect a tissue sample after the completion of surgery. Participants not having an infusion will have their tissue collected after surgery or biopsy. Participation in this study will not change patient care. All patients will receive standard of care treatment as determined by their doctors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients must have radiographic evidence of known or probable kidney or urothelial cancer requiring surgical biopsy or excision.

• Age ≥ 18 years

• Subjects of all races and ethnic origins

• The willingness to sign and ability to understand a written informed consent.

• Patients participating in other clinical trials are eligible, and will be evaluated on a case by case basis by the Principal Investigator, Dr. Vitaly Margulis, MD.

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Vitaly Margulis, MD
vitaly.margulis@utsouthwestern.edu
214-648-0567
Backup
Ralph J DeBerardinis, MD, PhD
ralph.deberardinis@utsouthwestern.edu
214-648-2585
Time Frame
Start Date: 2019-09-30
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 600
Treatments
Experimental: 13C-Glucose
Experimental: 13C-Acetate
Experimental: 13C-Lactate
Experimental: 13C-Glutamine
Experimental: 13C-Fructose
Sponsors
Collaborators: Howard Hughes Medical Institute, National Cancer Institute (NCI)
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov

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