RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-09-30
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04623502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have radiographic evidence of known or probable kidney or urothelial cancer requiring surgical biopsy or excision.
  2. * Age ≥ 18 years
  3. * Subjects of all races and ethnic origins
  4. * The willingness to sign and ability to understand a written informed consent.
  5. * 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.
  1. * Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion
  2. * Pregnant or breastfeeding
  3. * Not a surgical candidate

Contacts and Locations

Study Contact

Vitaly Margulis, MD
CONTACT
214-648-0567
vitaly.margulis@utsouthwestern.edu
Ralph J DeBerardinis, MD, PhD
CONTACT
214-648-2585
ralph.deberardinis@utsouthwestern.edu

Principal Investigator

Vitaly Margulis, MD
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Vitaly Margulis, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-30
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2019-09-30
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Cancer
  • Renal Cell Carcinoma
  • Clear Cell Carcinoma
  • Urothelial Carcinoma
  • Metastatic Kidney Cancer
  • Metastatic Urothelial Carcinoma
  • Papillary Renal Cell Carcinoma
  • Chromophobe Renal Cell Carcinoma
  • Fumarate Hydratase Deficiency
  • Succinate Dehydrogenase-Deficient Renal Cell Carcinoma
  • HLRCC
  • Hereditary Leiomyomatosis and Renal Cell Cancer