Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures

Active, not recruiting

• Conditions: Obesity
• Interventions: Procedure: Adults presenting for surgery in the neck area

• Registration Number: NCT02274805
• Lead Sponsor: AdventHealth Translational Research Institute

Brief Summary

The purpose of the study is to gather tissue (from the neck region), specimens (blood and urine) and medical record data from many patients and store them in one place so that scientists have the information they need to conduct research and learn about new ways to predict, identify and treat illness, specifically those related to obesity and diabetes.

Detailed Description

This protocol is designed to actively collect biospecimens (specifically, tissue from the neck region) and clinical data for donation to the TRI-MD, specifically, Dr. Sparks' laboratory. These specimens and data will be available to Dr. Sparks for future research activity in accordance with the Florida Hospital and Translational Research Institute for Metabolism and Diabetes (TRI) policies.

Study Timeline

• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2014-11
• Primary Completion: 2019-04-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Adults aged 18 and older presenting for surgery in the neck area
• Able to provide informed consent

Exclusion Criteria

• Unable to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults presenting for surgery in the neck area	Adults presenting for surgery in the neck area	-

Primary Outcome Measures

Name	Time	Method
Collection of brown adipose neck tissue	Day of scheduled surgery	Any tissue deemed suitable by the surgeon and/or the research team during the neck surgery for the study's research objectives will be removed and collected for donation to this protocol. When there is enough tissue available, half will be snap frozen for extraction of DNA, RNA and protein. The other half will be cryopreserved for the future production of viable cells. When there is not enough tissue, the person collecting the samples will determine the processing. For research purposes, we aim to collect up to 500mg of each tissue.

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States