The Netherlands ME/CFS Cohort and Biobank (NMCB)

• Conditions: neurological disorders; disorders with unknown etiology; chronic fatigue syndrome; Myalgic Encephalomyelitis; 10003816

• Registration Number: NL-OMON56812
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 2100

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 with verification by a medical doctor (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.

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

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 >= 3, indicating major depressive disorder;
- Pregnant or breastfeeding in the past 12 months;
- BMI >40;
- Age <18 or >65 years.

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified