Chronic Fatigue SyndromeCHROMENCT04859257
Exploring the Biological Basis of Chronic Fatigue Syndrome
An observational study of Chronic Fatigue Syndrome, run by DxTerity Diagnostics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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 -
- 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)
Who cannot join
- Pregnancy
- 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).
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
DxTerity Diagnostics Inc.
Compton, California, 90220
About this study
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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start26 May 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- DxTerity Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859257
- Sponsor's protocol ID
- DXT-MCD-AH01
- Acronym
- CHROME
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Biological Basis of Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT04859257
- Acronym / sponsor ID
- CHROME / DXT-MCD-AH01
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- DxTerity DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (9 listed)
- Pregnancy
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by DxTerity Diagnostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.