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Announcing the ME / CFS Severely Ill-BIG DATA Study

After a careful review of what is needed to “End ME / CFS,” our ME / CFS Scientific Advisory Board determined the first  step is to look for answers in an often overlooked population in ME / CFS research: the severely ill. While the board director, Ronald W. Davis, PhD, has a son with a severe case of the disease, it also makes scientific sense to research these patients.

“Hopefully, the more severely ill will have a stronger signal of what’s going wrong,” said Davis. “As a result, we won’t need as many patients.”

Yet, very little research has been done in the bedbound patients because they are hard to reach. By looking in many areas of the body of the severely ill, we may discover distinctive biomarkers that have not been found in previous ME / CFS studies. By then testing these biomarkers in the less severely ill, we may discover an inexpensive and clinically useful diagnostic test.

“OMF has brought together a high caliber of scientists and laboratories with methods to approach this biomarker search and urgent research in depth,” said OMF Executive Director Linda Tannenbaum. “We will start with a few patients with our current funding. We urgently need more funding to increase the patient size and make this happen.

Donate Study SquareStudy Features and Goals

As part of our End ME / CFS Project, this study will conduct a comprehensive, “Big Data,” analysis on severely ill ME / CFS patients with the goal of finding sensitive  and distinctive molecular biomarker(s).  The molecular biomarkers that reflect the symptom mechanism are expected to be strongest in the approximately 25% of ME / CFS patients who have a severe form of the disease and are home-bound or bedbound.

Although many of the symptoms are neurological, neurological diseases often produce molecular biomarker(s) that may be found in the blood, saliva, sweat, urine and feces. Identifying biomarker(s) in these easily assayed fluids can be convenient, inexpensive and can be conducted on bedbound patients. Such an easy and distinguishing test is more likely to be diagnostically useful in the clinical setting.

The source of the potential diagnostic biomarker(s) is not immediately obvious; it could be in the DNA, RNA, proteins, carbohydrates or metabolites, or could be from an associated microbe in or on the body.

In addition to increasing the accuracy of diagnosing ME / CFS, a distinctive biomarker that correlates with symptom severity could reveal the disease structure or mechanism. So the second phase of this  study will aim to  test the discovered biomarkers in the less severely ill to see if they are present but possibly not as strong. Discovering biomarkers that go up or down with symptom severity will provide targets for treatment trials. Additionally, treatment trials can also reveal more about the disease mechanism.

Many previous studies look for one thing or test only one biological area in a group of patients. Discovering a mixed biomarker set from different body systems would require that all of the analysis be conducted on the same patient, instead of piecemeal studies on different patients in different studies. Such a comprehensive analysis may reveal how the different systems malfunction at the same time and possibly together contribute to the disease mechanism.

A comprehensive biological analysis in each patient in the study could also reveal that different mechanisms in different patients lead to the same symptoms. Finding these differing biomarkers in different patients would identify subgroups that can then also be subjects for targeted treatment trials.

Conducting all of these molecular investigations with state-of-the-art methodologies on well-described patients will be a daunting task. It will require significant resources and considerable coordination and cooperation within the scientific and medical communities. For the first phase of this study, our goal is to raise $1 million. Gaining the extensive data set will require $25,000 per patient for logistics and supplies. We will do these tests on as many patients as we can with the funds we raise. Pleas join our team of HOPE and be a part of this historic effort to find a diagnostic biomarker. Please, donate toward this study today.

Read a detailed explanation of this study, including the specific tests that are included.

Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS) Post Treatment Lyme Disease Syndrome (PTLDS), Fibromyalgia Leading Research. Delivering Hope.Open Medicine Foundation®

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