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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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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):
Exclusion Criteria:
Inclusion Criteria: (Cohort 2)
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):
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DxTerity Diagnostics Inc. | Compton | California | 90220 | United States |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |