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Brief Title: Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy

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

INTRODUCTION

  • Org Study ID: STU2019-1061
  • Secondary ID: P50CA196516, R35CA220449, F31CA239330, HHMI Investigator:DeBerardinis
  • NTC ID: NCT04623502
  • Sponsor: University of Texas Southwestern Medical Center

BRIEF 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.

DETAILED DESCRIPTION

The purpose of this study is to understand the metabolism of kidney cancers (renal cell carcinomas and urothelial cell carcinomas involving the kidney) in patients. Metabolism is the term used to describe how cells take up different nutrients and convert them to energy and materials needed for cell growth. In cancer, metabolism is hijacked to support the needs of cancer cells. Cancer cells can use multiple nutrients in the blood to fuel their growth, but it is not known what materials cancer cells make with those nutrients in patients.

Many participants in this study will be infused with a 13C-labeled nutrient during their surgery or biopsy. 13C means that the carbon in the nutrient is heavier than 12C carbons that are the most abundant carbon atoms in nature. 13C carbons account for about 1% of natural carbon atoms are not radioactive or harmful in any way. Using the tissue collected during or after surgery and/or biopsy, the researchers can track how the heavier 13C carbons from the infused nutrient are being used to make different materials that cancer cells need to grow.

The researchers hope to understand how kidney cancers change their metabolism to adapt, grow, and survive in patients. The knowledge learned from this study will be used to support the development of therapies that target metabolic adaptations, and the development of new non-invasive imaging techniques that will improve the care and survival of future kidney cancer patients.

  • Overall Status
    Recruiting
  • Start Date
    September 30, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Percent of 13C isotopologue distributions

Primary Outcome 1 - Timeframe: 5 years

CONDITION

  • 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

ELIGIBILITY

Inclusion Criteria:
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.
Exclusion Criteria:
Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion

- Pregnant or breastfeeding

- Not a surgical candidate

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

OFFICIAL INFORMATION

Name: Vitaly Margulis, MD

Role: Principal Investigator

Affiliation: University of Texas Southwestern Medical Center

Overall Contact

Name: Vitaly Margulis, MD

Phone: 214-648-0567, 214-648-2585

Email: vitaly.margulis@utsouthwestern.edu, ralph.deberardinis@utsouthwestern.edu

LOCATION

Facility Status Contact
Facility: University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Vitaly Margulis
214-648-0567
vitaly.margulis@utsouthwestern.edu