NCT03621124|TerminatedDMC
Study Stopped
COVID-19 Pandemic
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Sponsor study identifier
Secondary identifiers
observational
3
1 country
1
Study Start
August 16, 2018
Actual (reported)Primary Completion
May 20, 2020
Actual (reported)Study Completion
May 20, 2020
Actual (reported)The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2018
Actual (reported)August 8, 2018
Actual (reported)August 16, 2018
Actual (reported)May 20, 2020
Actual (reported)May 20, 2020
Actual (reported)Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.
Characterization of the energy metabolism profiles of cancer patients with and without evidence of BAT activation will be assessed utilizing one sided t-test.
27 Months
Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.
27 Months
Patients with known malignancy and incidental finding of positron emission tomography/ computerized tomography (PET/CT) scans positive for brown adipose tissue (BAT). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.
Patients with known malignancy and no evidence of brown adipose tissue BAT activity positron emission tomography/ computerized tomography (PET/CT) scans to be matched to group 1 for primary tumor and stage, sex, age (±5 years), BMI (±3 Kg/m2). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.
During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
Patients equal to or greater than forty years of age with an active cancer diagnosis.
Virginia Commonwealth University/ Massey Cancer Center
Richmond, Virginia, 23298-0070, United States
Francesco S Celi, MD, MHSc
Virginia Commonwealth University
3 participants (actual enrollment reported by the registry).
First Submitted
August 1, 2018
First Posted
August 8, 2018
Study Start
August 16, 2018
Actual (reported)Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 20, 2020
Actual (reported)Study Completion
May 20, 2020
Actual (reported)Last Updated
April 13, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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