Exploring the Biological Basis of Chronic Fatigue Syndrome

NCT04859257 | Completed

• 1 other identifier: DXT-MCD-AH01
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (3)

• Collect blood samples from patients with Chronic Fatigue Syndrome (CFS), myalgic encephalomyelitis (ME), and Systemic Exertion Intolerance Syndrome (SEID), and controls for genomic testing.

  To enable research focused on discriminating differentiated symptoms of various sources of CFS from other autoimmune and viral pathogenesis of disease which could prove valuable in researching for inflammation and immunity related therapeutics.

  3 months

• Collect blood samples from patients with Chronic Fatigue Syndrome (CFS), myalgic encephalomyelitis (ME), and Systemic Exertion Intolerance Syndrome (SEID), and controls for viral testing.

  To enable research focused on discriminating differentiated symptoms of various sources of CFS from other autoimmune and viral pathogenesis of disease which could prove valuable in researching for inflammation and immunity related therapeutics.

  3 months

• Collect urine samples from patients with Chronic Fatigue Syndrome (CFS), myalgic encephalomyelitis (ME), and Systemic Exertion Intolerance Syndrome (SEID), and controls for metabolomic testing.

  To enable research focused on discriminating differentiated symptoms of various sources of CFS from other autoimmune and viral pathogenesis of disease which could prove valuable in researching for inflammation and immunity related therapeutics.

  3 months

Study Arms (2)

Disease Group

Cohort 1 (Disease Group) of the study will collect blood and urine samples from participants who are either diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) or experience symptoms of profound fatigue based on the cohort specific inclusion criteria.

Control Group

Cohort 2 (Control Group) of the study will collect blood and urine samples from participants who have NOT been diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) or experience symptoms of profound fatigue based on the cohort specific exclusion criteria.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1 of this study will collect blood sample and a urine sample from up to 150 subjects who are either diagnosed with CFS/ME or experience symptoms of fatigue. Cohort 2 (Control Group) of the study will collect blood and urine samples from participants who have NOT been diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) or experience symptoms of profound fatigue based on the cohort specific exclusion criteria.

You may qualify if:

• Male and female patients age 18 or older at the time of consent
• Have a permanent address in the United States for the duration of the study
• Have an email address and access to the internet for the duration of the study
• Able to provide unassisted informed consent
• Medical Record Consent (optional)
• Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR
• Report experiencing one or more of the following symptoms (record all that apply):
• Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months
• Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).
• Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep
• Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR
• Worsening of symptoms while standing or sitting upright -

You may not qualify if:

• Pregnancy
• Male and female patients age 18 or older at the time of consent
• Have a permanent address in the United States for the duration of the study
• Have an email address and access to the internet for the duration of the study
• Able to provide unassisted informed consent
• Medical Record Consent (optional)
• Pregnant
• Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR
• Report experiencing one or more of the following symptoms (record all that apply):
• Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months
• Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).
• Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep
• Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR
• Worsening of symptoms while standing or sitting upright

Sponsors & Collaborators

• DxTerity Diagnostics: lead

Study Sites (1)

DxTerity Diagnostics Inc.

Compton, California, 90220, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: May 26, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

US (1)