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CHROME: Exploring the Biological Basis of Chronic Fatigue Syndrome

Sponsor
DxTerity Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT04859257
Collaborator
(none)
380
Enrollment
1
Location
6.2
Actual Duration (Months)
61.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    380 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exploring the Biological Basis of Chronic Fatigue Syndrome
    Actual Study Start Date :
    May 26, 2021
    Actual Primary Completion Date :
    Dec 1, 2021
    Actual Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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):

    8. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months

    9. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).

    10. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep

    11. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR

    12. 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):

    4. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months

    5. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).

    6. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep

    7. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR

    8. Worsening of symptoms while standing or sitting upright

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DxTerity Diagnostics Inc. Compton California United States 90220

    Sponsors and Collaborators

    • DxTerity Diagnostics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DxTerity Diagnostics
    ClinicalTrials.gov Identifier:
    NCT04859257
    Other Study ID Numbers:
    • DXT-MCD-AH01
    First Posted:
    Apr 26, 2021
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Fatigue Syndrome, Chronic
    Syndrome
    Fatigue

    Study Results

    No Results Posted as of Feb 15, 2022