NCT04623502 An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
| NCT ID | NCT04623502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Kidney Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2019-09-30 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2019-09-30 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Vitaly Margulis, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT04623502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04623502 currently recruiting?
Yes, NCT04623502 is actively recruiting participants. Contact the research team at vitaly.margulis@utsouthwestern.edu for enrollment information.
Where is the NCT04623502 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT04623502 clinical trial?
NCT04623502 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Vitaly Margulis, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 600 participants.
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