Open US: The CHROME (CHRonic Fatigue SyndrOME) study

"Study participants will complete a kit + questionnaire to establish their CFS activity. A small fraction of participants will be asked to complete a second kit + questionnaire 1-2 weeks following the first sample collection. Participants may give permission to review their medical records, serving as another data source, but will not be required to do so. Providing medical record access helps researchers make connections between each participant’s blood and urine samples and their medical history.

Researchers will use self-reported information and medical records to understand the collected samples better by making connections between each participant’s blood and urine chemistry and their medical history."

https://thechromestudy.com/how-this-study-works/


"You qualify for the CHROME Study if you:

• Have been diagnosed with Chronic Fatigue Syndrome by a healthcare professional
• Are able to use our DxCollect® Fingerstick and urine sample collection kit to send a sample
• Have access to a computer, tablet, or smartphone to be able to take health surveys"

https://thechromestudy.com/do-you-qualify/

 

Do you know who is running this study @Andy?

 

"DxTerity is sponsoring the CHROME study. DxTerity is a Los Angeles-based research company that uses state of the art technologies to analyze DNA and RNA. They also developed the DxCollect® Kit (used in CHROME) for easy at-home collection of fingerstick blood samples. DxTerity will be analyzing the samples and information collected during CHROME to better understand the signs and symptoms of CFS, improving diagnostics and treatment options."

Hm.

 

Ariel has quoted the information given, the rest of the FAQ, such as it is, can be seen here, https://thechromestudy.com/faq/

Unless I missed it, they aren't specifying any particular definition of ME, so my assumption is that they are relying on that clinicians diagnosis of CFS to give them the right patients. If that's right then as evidence goes this won't be totally useless, but pretty close.

 

After giving them my email address, this is what I received.

 

Is there any point in emailing them to ask what case definition/criteria they are using?

 

I've been left with the impression that the NIH and some of our own charities have a hard time finding people with ME/CFS to participate in their studies. I was blindsided by the overwhelming response they are receiving. I think the ease of this study is appealing to pwME.

 

I was sent a link to download an app to my phone. After creating an account, I ordered a test kit.

The kit contains an odd single-use lancet, (thankfully they sent two as one failed), and a tube for urine. There's a collection cup and suction bulb for getting the urine into its tube. There's a block that goes in the freezer for keeping the urine frozen during shipping.

I collected my urine this morning before breakfast. The urine needs to be in the freezer for 2 hours before being shipped. After eating and resting a bit, I collected my blood sample. They need to be shipped on the day of collection.

The urine is shipped using FedEx. The blood is shipped using USPS.

I hope this makes sense because I'm foggy.

 

What are they looking for exactly? do they say?

 

Somewhere there's a researcher, perhaps in Bristol, kicking themselves for not coming up with this study name first.

 

They give no details.

 

Brief 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.

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.

https://clinicaltrials.gov/ct2/show/NCT04859257

 

I wonder if they are in touch with any US ME orgs?