Exploring the Biological Basis of Chronic Fatigue Syndrome (CHROME)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 380

Contacts and Locations

Study Locations

• United States
  • California
    • Compton, California, United States, 90220
      • DxTerity Diagnostics Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria: (Cohort 1)

1. Male and female patients age 18 or older at the time of consent
2. Have a permanent address in the United States for the duration of the study
3. Have an email address and access to the internet for the duration of the study
4. Able to provide unassisted informed consent
5. Medical Record Consent (optional)
6. Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR

7. Report experiencing one or more of the following symptoms (record all that apply):

   1. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months
   2. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).
   3. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep
   4. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR
   5. Worsening of symptoms while standing or sitting upright -

Exclusion Criteria:

• Pregnancy

Inclusion Criteria: (Cohort 2)

1. Male and female patients age 18 or older at the time of consent
2. Have a permanent address in the United States for the duration of the study
3. Have an email address and access to the internet for the duration of the study
4. Able to provide unassisted informed consent
5. Medical Record Consent (optional)

Exclusion Criteria:

1. Pregnant
2. Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR

3. Report experiencing one or more of the following symptoms (record all that apply):

   1. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months
   2. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).
   3. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep
   4. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR
   5. Worsening of symptoms while standing or sitting upright

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: DxTerity Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: DXT-MCD-AH01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No