NCT04785989 In Vivo Metabolic Profiling of CLL (Chronic Lymphocytic Leukemia)
| NCT ID | NCT04785989 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Madison |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2022-06-13 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2022-06-13 with a primary completion date of 2026-10.
⚠ 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
Metabolic reprogramming has been identified as a hallmark of cancer. Almost a century after Otto Warburg initially discovered increased glycolytic activity in tumor tissue ("Warburg effect"), therapeutic targeting of cancer metabolism has become a field of intense research effort in cancer biology. A growing appreciation of metabolic heterogeneity and complexity is currently reshaping investigators "simplistic" understanding of metabolic reprogramming in cancer. Discovering metabolic vulnerabilities as new treatment targets for cancer requires systematic dissection of metabolic dependencies, fuel preferences, and underlying mechanisms in the specific physiological context. However, today's data on cancer cell metabolic signatures and heterogeneity in their physiological habitat of the human organism is sparse to non-existent representing a critical knowledge gap in designing effective metabolic therapies. Here, the investigators propose a "top-down" approach studying cancer cell metabolism in patients followed by mechanistic in-depth studies in cell culture and animal models to define metabolic vulnerabilities. Investigators will develop a metabolic tracing method to quantitatively characterize metabolic signatures and fuel preferences of leukemic lymphocytes in patients with chronic lymphocytic leukemia (CLL). Isotopic metabolic tracers are nutrients that are chemically identical to the native nutrient. Incorporated stable, non-radioactive isotopes allow investigators to follow their metabolic fate by monitoring conversion of tracer nutrients into downstream metabolites using cutting-edge metabolomics analysis. Using this method, investigators propose to test the hypothesis that leukemic lymphocytes show tissue-specific metabolic preferences that differ from non-leukemic lymphocytes and that ex vivo in-plasma labeling represents a useful model for assaying metabolic activity in leukemic cells in a patient-specific manner.
Eligibility Criteria
Inclusion Criteria: Group A * Adult (18 years of age or older) * No previous history of cancer * Routine history of normal blood counts and vital signs * Documented Informed Consent Group B * Adult (18 years of age or older) * Diagnosis of CLL with low disease burden defined as Rai stage 0 ((Lymphocytosis; no enlargement of the lymph nodes, spleen, or liver; red blood cell and platelet counts are near normal.) * Treatment naïve * Documented Informed Consent Group C * Adult (18 years of age or older) * Diagnosis of CLL with high systemic disease burden defined as infiltration of bone marrow causing cytopenia * Treatment naïve * Able/willing to have bone marrow aspiration * Documented Informed Consent Exclusion Criteria: For all participants * Prisoners * Psychiatric inpatients or people who are institutionalized * Minor (Less than 18 years of age) * History of diabetes * Cannot be on antihyperglycemic therapy * Carbohydrate restricting diets: Atkins, Vegan, Ketogenic, etc. * Females of child bearing potential * Persons without decision-making capacity * Person who cannot read/write English * Not meeting inclusion criteria defined above
Contact & Investigator
Christopher Fletcher, MD
PRINCIPAL INVESTIGATOR
School of Medicine and Public Health, University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT04785989 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04785989 currently recruiting?
Yes, NCT04785989 is actively recruiting participants. Contact the research team at clinicaltrials@cancer.wisc.edu for enrollment information.
Where is the NCT04785989 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT04785989 clinical trial?
NCT04785989 is sponsored by University of Wisconsin, Madison. The principal investigator is Christopher Fletcher, MD at School of Medicine and Public Health, University of Wisconsin, Madison. The trial plans to enroll 16 participants.
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