chronic fatigue syndrome Myalgic Encephalomyelitis ME/CFS
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: - The ability to provide informed consent. - A willingness and ability to comply with all aspects of the protocol, including physical assessments and biospecimen collections. In addition to the general inclusion criteria, ME/CFS patients must meet the following criteria: - A diagnosis of ME/CFS made by a medical doctor (self-reported) (i.e., excluding alternative diagnoses). A diagnosis in this context implies meeting the case definitions as established according to (either/or) the CDC-94 criteria (also called the Fukuda criteria (4)), the Canadian Consensus Criteria (CCC) (3), the International Consensus Criteria (ICC) (21), or Institute of Medicine (IOM) (22) case definitions. These symptom definitions will be established in an interview and a physical assessment by well-trained personnel. For MRI: - A willingness and ability to comply with all aspects of the MRI protocol. In addition to the general inclusion criteria, clinical controls must meet the following criteria: - A diagnosis of MS, Q-fever, long-COVID, or Lyme*s disease. With the exception of MS, if any of the clinical controls with Q-fever, long-COVID, or Lyme*s disease meet ME/CFS case definitions, they will be invited to join the study as an ME/CFS case.
Exclusion criteria
Exclusion criteria: All participants: - Taking immune modulatory drugs in the past 3 months; - Having a serious medical condition that may explain ME/CFS-like symptoms, such as cancer, coronary heart disease, uncontrolled diabetes, chronic infection (hepatitis B and C, tuberculosis, HIV), inflammatory disorders, autoimmune diseases (e.g. rheumatoid arthritis, lupus, or polymyositis), severe COPD or other severe ongoing respiratory disease, severe anaemia, kidney failure, Addison*s or Cushing*s disease, or serious neurological disorder (e.g. Parkinson*s Disease); - Excessive consumption of alcohol or recreational drugs as defined by a score > 2 on the CAGE-AID survey; - Unwillingness to stop consumption of alcohol and recreational drugs for at least 48 hours prior to the study visit; - A mood disorder or other psychiatric diagnosis, determined by asking if they have a mood disorder or other psychiatric diagnosis, and if they are taking medication for their diagnosis, prior to entering the study. As part of checking a potential participant*s eligibility for the study, they will be asked to fill in the Participant Health Questionnaire-2 to determine if they have a score of >= 5, indicating major depressive disorder; A score of = 4 will be used for participants taking anti-depressants. - Pregnant or breastfeeding in the past 12 months; - BMI >40; - Age <18 or >65 years. For MRI: -patients who are unable to lay still for scanning due to claustrophobia or severe back pain - history of gross neurological pathology (strategic or lobar infarcts or stroke or neurotrauma) prior to enrolment (besides a serious neurological disorder) In addition, for healthy controls and Multiple Sclerosis controls: - No previous diagnosis of ME/CFS; - Not meeting either of CDC94/CCC/ICC/IOM case definitions, according to the DePaul Symptom Questionnaire.For the muscle biopsy subset of patients:-BMI > 30 due to adiposity, since this is known to cause difficulties in obtaining muscle biopsies-Blood anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All 2100 participants (including ME/CFS patients, healthy and clinical controls) will be assessed at one time point for phenotypic characterization. We will collect self-report (demographic (including ethnicity), behavioral, symptoms), clinical, and neurocognitive data, coupled with the collection of biomaterials for a national biobank. Cohort-wide analyses such as whole genome sequencing, RNA sequencing, and measurements of cells, proteins or compounds are both part of the primary study objective to characterize ME/CFS patients, as well as part of the secondary objective to have this data available in a large and extensive biobank, along with additional biomaterials for specific research questions. | — |
Secondary
| Measure | Time frame |
|---|---|
| The collection of biomaterials for a national biobank for storing plasma, serum, PBMCs, DNA, RNA, nasal swabs, and saliva, urine and fecal samples. Cohort-wide measured data of part of the materials (i.e. RNA sequencing of all PAXgene whole blood samples under the scope of this study protocol) will be part of the biobank. MRI-results (for part of the subjects) | — |
Countries
Netherlands
Contacts
Public ContactJA Bosch
Amsterdam UMC
Outcome results
None listed