SolveCFS Biobank Beginning

[jspotila]

Full text of announcement can be found on the SolveCFS website, including criteria for participation, consent form, etc.

The SolveCFS BioBank will collect and store a bank of biological samples (such as blood, tissue, cells and DNA) and clinical information at the Genetic Alliance laboratory facility from individuals with CFS and unaffected individuals aged 10 and older. The samples and information will be used by approved researchers to identify biomarkers, explore the causes of and potential treatments for CFS.

. . .

Collection of biological samples and clinical information is for the sole purpose of advancing research. Participants in the SolveCFS BioBank will not receive personal results about any tests performed using their samples. The CFIDS Association of America will periodically inform the patient and research communities about how SolveCFS BioBank samples are being used, as well as the results of research conducted. Researchers will be required to publish their results in peer-reviewed medical journals. Participants may be recontacted from time-to-time by the Association to update demographic, mailing and clinical information, to provide additional samples as new studies are approved, or to participate in other types of follow-up research.

In compliance with the design for the initial BioBank studies, patients are being recruited by collaborating expert CFS clinicians to ensure that subjects in the study have well-characterized CFS. Family members and neighborhood control subjects who are in good health will also be invited to participate. All interested persons must be at least 10 years old to participate and must give informed consent before being enrolled in the SolveCFS BioBank.

 

[jspotila]

CFIDSLink Story on Biobank

A special CFIDSLink announcement went out today that explains how the Biobank idea was developed and how it fits into the Association's research program overall.

When the CFIDS Association launched its expanded research initiative in mid-2007, we heard loudly and clearly from the CFS community that research was its top priority. In response, we:

* recruited a full-time scientific director;

* issued a Request for Applications focused on biomarkers and methods for early detection, objective diagnosis and effective treatment of CFS;

* adopted updated funding policies;

* strengthened our peer review system;

* awarded six innovative grants;

* established the first funded network of linked investigators;

* convened an intensive three-day meeting of experts;

* conducted site visits of funded projects; and

* kept the community informed about our progress using a host of print and electronic publications, recently expanded to include regular webinar programs.

When scientific director Suzanne D. Vernon, PhD, joined our staff in late 2007, one of her goals was to fill scientific "infrastructure" gaps she believed were barriers to attracting new investigators and validating some of the known biological markers published by research groups in the U.S. and other countries. Linking bench researchers to well-defined clinical populations was one of the foremost challenges.

In September 2009, Suzanne completed her certificate in public health genomics at Sarah Lawrence College and she met leaders from Genetic Alliance (GA), a network of more than 1,000 disease-specific advocacy organizations committed to transforming health through genetics. Suzanne discovered how GA had created a centralized registry and repository to enable translational research for a host of underfunded and rare conditions, addressing the cohort access issue.

Genetic Alliance president Sharon Terry recounts her goal in establishing the GA BioBank with other leaders in disease research advocacy: "The Genetic Alliance BioBank was built with organizations like the CFIDS Association in mind - to provide them with the infrastructure to pursue sophisticated, novel research collaborations with academia and industry to develop new diagnostics and therapeutics to better understand and treat disease."

Suzanne conducted her own careful research, comparing the Genetic Alliance model to several others, weighing the costs and benefits to the organization, the patient community and researchers in academia and industry. Summarizing her findings, she told our board of directors last fall, "The Genetic Alliance uses a cooperative, cost-sharing model that translates into a tightly controlled, comprehensive infrastructure for biobanking. Organizations that start from scratch often spend millions of dollars just to put the systems and documentation in place before a single sample is collected."

Genetic Alliance set high standards for participant involvement in research, exceeding requirements of all applicable federal, state and local laws, rules and regulations. The GA BioBank earned a Certificate of Confidentiality from the National Institutes of Health. The GA's board of directors oversees the fiscal management and annual audit. It provides standardized protocols and allows for ethical re-contact and robust privacy and security protections. Our legal counsel agreed with the assessment.

In December, the Association's board of directors approved plans to join the Genetic Alliance BioBank and to apply for approval from GA's Internal Review Board (IRB) for the SolveCFS BioBank. Chairman of the board Adam Lesser recalls the discussion about initiating a biobank. "It was the next logical step to advance research in CFS, and Genetic Alliance offered tremendous capacity to augment our research program." Final approvals were granted by the IRB earlier this month.

On behalf of the board of directors and staff of the CFIDS Association of America, I am delighted to introduce the SolveCFS BioBank. The SolveCFS BioBank will collect and store a bank of biological samples (such as blood, tissue, cells and DNA) and clinical information at the GA BioBank laboratory facility from individuals with CFS and healthy individuals (controls) aged 10 and older from the U.S. and other countries. It ensures that individual privacy and confidentiality are protected and that samples are available to researchers whose research projects have been reviewed and approved by the CFIDS Association of America Medical Research Advisory Committee.

Through the SolveCFS BioBank, individuals can enroll once and will then contribute information to multiple projects, advancing our understanding of CFS on multiple fronts. Because the SolveCFS BioBank's purpose is dedicated to research and in order to preserve the privacy and security of all participants' information, participants do not receive personal results about any tests performed using their samples. The Association will provide regular updates about how SolveCFS BioBank samples are being used, as well as the results of research conducted. Researchers will be required to publish their results in peer-reviewed medical journals.

Since securing approval for the SolveCFS BioBank, the Association has established its first study collaboration. We are working with several clinical and academic collaborators and major industry partners. As such, enrollment criteria for the inaugural study will be rather strict. As Suzanne indicates, "The SolveCFS BioBank is an innovative research resource that will be used for validation of promising biomarkers, genetic studies, family studies and genomics research. It will be a resource for discovery, diagnostics and targeted treatments. We hope to have adequate funding soon to expand recruitment beyond the inaugural study requirements. This will truly empower more people affected by CFS to participate in this exciting research, and will ultimately lead to the answers we all seek."

We have recently updated our SolveCFS.org website to house extensive information about the SolveCFS BioBank. We look forward to sharing additional updates, news about expanded recruitment and, best of all, results from research that utilizes the SolveCFS BioBank.

We are grateful to Association supporters for making this new initiative possible. It is just one of many reasons that 2010 promises to be a year of important advances in making CFS widely understood, diagnosable, curable and preventable.

Sincerely,

K. Kimberly McCleary
President & CEO
The CFIDS Association of America

P.S. Please continue (or begin!) your support of these and other important Association efforts by making a tax-deductible gift today using our secure website.

 

[Gerwyn]

A special CFIDSLink announcement went out today that explains how the Biobank idea was developed and how it fits into the Association's research program overall.

how many of the patients will have post exhertional fatigue as mandatory

 

[CBS]

Jennie,

This is very impressive. I've read through the CFS patient and control criteria for the first phase and it is thorough. This is exactly the type of work that needs to be done. It addresses so many of the "Did they really use CFS patients in their study?" questions that have plagued CFS research for decades.

Thank you for your efforts.

Shane

 

[CBS]

how many of the patients will have post exhertional fatigue as mandatory

Gerwyn,

The guidelines state that participation requires subjects meet the Fukuda or Canadian Consensus Dx criteria. Here's the link to the Solve CFS Biobank criteria: http://www.solvecfs.org/SOLVECFSBIOBANK/CURRENTSTUDYCRITERIA/tabid/105/Default.aspx

Page Four, Item #2. I think the answer to your question is that anyone not experiencing post-exertional malaise (as defined by the Canadian or Fukuda criteria) will not qualify.

Again, way to go CAA.

 

[Gerwyn]

Gerwyn,

The guidelines state that participation requires subjects meet Fukuda and Canadian Consensus Dx criteria. Here's the link to the Solve CFS Biobank criteria: http://www.solvecfs.org/SOLVECFSBIOBANK/CURRENTSTUDYCRITERIA/tabid/105/Default.aspx

Page Four, Item #2. I think the answer to your question is that anyone not experiencing post-exertional malaise will not qualify.

Again, way to go CAA.

If that is true then my hat is truly off!

 

[leelaplay]

Fantastic news! Now to make sure that all researchers use it.

 

[Cort]

Here's the criteria for the first collaboration. They're using standard Fukuda criteria and focusing on these types of patients:

CFS patients will be preferentially selected if they have been diagnosed by the Canadian clinical criteria or have documented abnormal NK cell laboratory results.

I imagine they won't be hard to find. These physicians have been doing this for years. You have to have PEM to be diagnosed by the Canadian Criteria; nice to add in the one of the documented immune abnormalities in ME/CFS.

CFS Subjects

A subject will be eligible for inclusion in current SolveCFS BioBank studies if they have previously been diagnosed with CFS by either the Fukuda (1994) research criteria or the Canadian (2003) clinical criteria by one of these four physicians:

Lucinda Bateman, M.D., Fatigue and Fibromyalgia Consultation Clinic, Salt Lake City, Utah
Stephen Gluckman, M.D., University of Pennsylvania, Philadelphia, Pennsylvania
Nancy G. Klimas, M.D., University of Miami/Veterans Affairs Administration, Miami, Florida
Charles Lapp, M.D., Hunter-Hopkins Clinic, Charlotte, North Carolina

The general inclusion and exclusion criteria listed below also apply. CFS patients will be preferentially selected if they have been diagnosed by the Canadian clinical criteria or have documented abnormal NK cell laboratory results.

Consider using our online questionnaire to help determine if your symptom pattern generally fits the study requirements. Answers to your questions will not be captured by our system and are completely anonymous. This questionnaire is intended as a guideline only.

Requirements for participation in the BioBank may change as further collaborations develop. Please check www.SolveCFS.org frequently for updates about the SolveCFS BioBank.

General Inclusion Criteria for CFS Subjects You must fulfill these criteria in order to be eligible for the current studies:
1. CFS initial presentation with a flu-like illness or an acute (48 hours) or subacute

 

[CBS]

PEM and Fukuda or Canadian

The first phase of subjects must have been diagnosed with CFS by one of only four clinicians:

A subject will be eligible for inclusion in current SolveCFS BioBank studies if they have previously been diagnosed with CFS by either the Fukuda (1994) research criteria or the Canadian (2003) clinical criteria by one of these four physicians:

Lucinda Bateman, M.D., Fatigue and Fibromyalgia Consultation Clinic, Salt Lake City, Utah
Stephen Gluckman, M.D., University of Pennsylvania, Philadelphia, Pennsylvania
Nancy G. Klimas, M.D., University of Miami/Veterans Affairs Administration, Miami, Florida
Charles Lapp, M.D., Hunter-Hopkins Clinic, Charlotte, North Carolina

The general inclusion and exclusion criteria listed below also apply. CFS patients will be preferentially selected if they have been diagnosed by the Canadian clinical criteria or have documented abnormal NK cell laboratory results.

Gerwyn, Note my underline and the correction to my earlier post.

General Inclusion Criteria for CFS Subjects You must fulfill these criteria in order to be eligible for the current studies:
1. CFS initial presentation with a flu-like illness or an acute (48 hours) or subacute (four weeks) onset.
2. Fatigue persists for at least six months.
3. Post-exertional malaise lasting more than 24 hours.Inclusion is EITHER Canadian or Fukuda as diagnosed by one of the four physicians.
4. Significant cognitive impairment in short-term memory and concentration.
5. Age between 18 and 65 years at the time of signing the informed consent.
6. A female subject is eligible to participate if she is not pregnant, not within three months postpartum, and not currently lactating per self-report.

And either meet either Fukuda or Canadian consensus Dx criteria - (sorry, having a bit of a brain cramp day).

 

[Cort]

What is the 'first collaboration'? Are these physicians engaging in a study? Or is this the first group of physicians to contribute specimens to the biobank?

If this really gets going it could really speed things up for us. Research will be cheaper and faster. Researchers will be able to ask for less money (more chance of getting funding). Given that CFS is such a vague condition researchers will love to get their hands on well defined patients. Just the fact that we're in this international Genetic Alliance network will help; it means that the CAA and ME/CFS passed through whatever hurdles they imposed. That confers more legitimacy on us.

What I really hope is that researchers start snatching these samples up and get going on their studies. We've all waited too long for the: one and half years to prepare a proposal and see if it gets funded, two years to do it, one year to write it up, one year to get it published model This has to cut that down. Because you have a well characterized cohort you should get better results. Since you have alot of data on that cohort you can go back and mine it.

One thing I really like is how smart the CAA was to get into this network. They never could have done it on their own - obviously don't have that kind of money.

Where does the CAA plan to get its funding to expand the project from? Are they applying for grants? How much do they need?

It would be interesting to see the data patients are providing. Any one have any questionnaires?

 

[jspotila]

Here is the weblink of the BioBank announcement. My quote in post#2 did not have the hyperlinks in it.

Post-exertional malaise lasting more than 24 hours is required in order to be eligible under current study criteria. There are a number of other required criteria which you can read here.

Cort asked a number of questions about the collaborations, etc. Dr. Vernon will be doing a webinar explaining the process, sample collection and so on. The announcement of the BioBank includes some additional information, and more will be made available as soon as possible without violating confidentiality and other issues.

Cort also asked about funding. We are seeking support and hope to have diversified funding from individuals, foundations, grants and industry to ensure that the BioBank is a sustained resource for many years. The more funding we have, the more samples we can include in the BioBank. One of the reasons the Board approved creation of the BioBank through Genetic Alliance is that it is scalable.

 

[Gerwyn]

The first phase of subjects must have been diagnosed with CFS by one of only four clinicians:



Gerwyn, Note my underline and correction to my earlier post. Inclusion is EITHER Canadian or Fukuda as diagnosed by one of the four physicians. The requirement of post exertional malaise in the Fukuda is not quite as clearly delineated.

unless they all have post exhertional malaise then there is little point.This is not mandatory in FUKUDA.post exhertional malaise is the only sure way of excluding people with depressive illness and is the key symptom of mitochondrial dysfunction

The minimal criterea for feduka dont cut it

 

[Hope123]

Well, it's good to hear the details about this and I am glad that acute onset is being emphasized in the current criteria. Although acute vs. chronic onset may or may not distinguish CFS in the future, the fact that so many come down with this acutely and that this group is more easily definable than chronic onset (with a multitude of factors) argues for it being good initial working criteria.

I realize that there are legalities around this but I sincerely hope that the CAA will eventually make the results of any studies done available to individuals who participate in these studies. (i.e. you get to know your own individual and not just group results) There was a recent review article in one of the major journals about what researchers can to do increase participation and one of the top factors was participant interest in their own results. Indeed some research groups already do this. This might also help convince clinicians that something biological is happening as participants bring back results to their docs even if tests are not validated yet.

I also hope the CAA send out a press release to all CFS researchers/ clinicians about this to generate interest.

 

[starryeyes]

Hope wrote: Well, it's good to hear the details about this and I am glad that acute onset is being emphasized in the current criteria. Although acute vs. chronic onset may or may not distinguish CFS in the future, the fact that so many come down with this acutely and that this group is more easily definable than chronic onset (with a multitude of factors) argues for it being good initial working criteria.

Hope, thanks for writing that out. I'm very brainfogged and didn't catch that. Shorter posts are easier for me to comprehend right now.

This looks great!

 

[Cort]

unless they all have post exhertional malaise then there is little point.This is not mandatory in FUKUDA.post exhertional malaise is the only sure way of excluding people with depressive illness and is the key symptom of mitochondrial dysfunction

The minimal criterea for feduka dont cut it

I'm really not worried about mood disorder patients. These aren't psychologists who are going to get fed alot of mood disorder patients; they are well known ME/CFS experts whom CFS patients usually find after a long search through other doctors. Since they've been doing this for so many years these doctors know in their bones know what a CFS patient looks like. We're not going to get mood disorder patients masquerading as CFS patients in this group. I'm not worried about that.

I see Jennie pointed out that PEM is required . So good news.

You must fulfill all these criteria in order to be eligible for the current studies:

1. CFS initial presentation with a flu-like illness or an acute (48 hours) or subacute (four weeks) onset.
2. Fatigue persists for at least six months.
3. Post-exertional malaise lasting more than 24 hours.
4. Significant cognitive impairment in short-term memory and concentration.
5. Age between 18 and 65 years at the time of signing the informed consent.
6. A female subject is eligible to participate if she is not pregnant, not within three

This is the first time that I know of that PEM is required in study subjects - that's been a long time coming!

 

[Robin]

Participants in the SolveCFS BioBank will not receive personal results about any tests performed using their samples.

I've never participated in research before. Is it standard to exclude results from patients?

 

[Hope123]

I've never participated in research before. Is it standard to exclude results from patients?

Robin, this is what I was alluding to in my post above. It's very common that participants do not know their individual results which is why the JAMA paper on increasing patient participation is interesting in that it points this out as something to consider changing in the future.

 

[jspotila]

Regarding the fact that BioBank participants will not receive individualized test results, this was a requirement by Genetic Alliance's IRB (Internal Review Board). I understand why patients, especially CFS patients, would want individualized results. I always wished that I could have results from the studies I participated in years ago. As I said, this is a requirement from the IRB, and the pros of creating a BioBank in this incredibly economic way have to be weighed against other interests/concerns. It is essential that any patient who donates to the BioBank be fully informed and give true consent. Each individual can and should make the choice based on the factors important to him or her.

 

[creekfeet]

Well, dang, I've got some great endometrial tissue coming available on the 9th of April, but I doubt I can get sufficiently qualified by then. I know I fit the strictest criteria but haven't had doctors who ran very thorough tests. Just a lot of "complete" blood counts, a chest xray, nonsense. Oh yeah, EBV +. And diagnosis is CFS and Fibro. So, chances of getting qualified in time to make use of all that great glop?

 

[Kati]

Creek, you need to have been diagnosed by only the 4 doctors mentioned in the document-

That's too bad because it would be great to put your endometrium to good use.