NCT04859257

Exploring the Biological Basis of Chronic Fatigue Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 380 (actual)
• Sponsor: DxTerity Diagnostics · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

To collect blood and urine samples from patients with Chronic Fatigue Syndrome (CFS), myalgic encephalomyelitis (ME), and SEID (Systemic Exertion Intolerance Syndrome) and controls for genomic, viral and metabolomic testing.

Detailed description

To analyze gene expression (genomic) and viral analysis data from patients diagnosed with ME/CFS, the study will collect blood samples (finger stick) and information from up to 500 subjects for analysis. In addition, urine will be collected for all subjects to evaluate the study subject's metabolomics. All participants will complete a single Study Collection event consisting of at least one MCD (2nd sample is optional) and one urine collection from home: 10% of each group (ME/CFS and Control) will complete a second Study Collection event approximately 1 to 2 weeks after the initial Study Collection. The second collection is to compare data between two collections from the same participants to observe any time-related changes in the results.

Conditions

• Chronic Fatigue Syndrome

Timeline

• Start date: 2021-05-26
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-04-26
• Last updated: 2022-02-15

Locations

1 site across 1 country: United States