Exploring the Biological Basis of Chron… | Clinical Trial

Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

DxTerity Diagnostics Inc.

Compton, California, 90220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Cohort 1)

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 -

Exclusion criteria

Pregnancy

Inclusion criteria

(Cohort 2)

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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Time frame: 3 months

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

Time frame: 3 months

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

Time frame: 3 months

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.

Sponsors and collaborators

Lead sponsor

DxTerity Diagnostics

Industry

Registry information

Acronym: CHROME

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Apr 26, 2021
Registry last updated: Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed