Introduction + STOPSC question- why 5 year limit?

[Guest guest]

Hi Everyone,

I'm new to the group & have enjoyed lurking. Folks here are simply

wonderful-I'll post more soon, but have a question about the PSC

study, STOPSC. Thanks to this group & to for telling me

about this study.

At Xmas, I signed up for the STOPSC study, and we have started

gathering my medical records.

However, I just received bad news from the clinical coordinator:

" In regards to the STOPSC study, thank you for faxing the signed

informed consent but unfortunately after reviewing some information I

learned

that since you were diagnosed with PSC more than 5 years ago you do not

meet the inclusion criteria for the study. Therefore, your information

will not be used for any data collection and any information we had

collected has been shredded. I thank you very much for taking the time

to learn about the study and answer our questions. Perhaps we can

contact you for future PSC studies. "

I was diagnosed in '93, so have had this disease for ~15 years now.

I'm extremely disappointed that STOPSC excludes diagnoses older than 5

years.

Anyone know why there is a 5 year old limit and if this can be changed?

This means a LOT of valuable information on disease progression will

not be included NOW and we'll have to wait years for the statistics to

be gathered just do document the typical disease progression. Never

mind that it is a rare disease, and there are not a lot of data points

to begin with!

I have every single medical record since my diagnosis, and want this

information available to help understand this disease and help other

people if at all possible.

Seems a total and complete waste to exclude folks like me with a well

documented history & enthusiasm about participating.

Is this 5 year exclusion something that this support group can try to

negotiate a change to? We really need all the good data we can get.

Thank-you for your time.

Best Regards,

DJ

PSC '93, 2.5g Urso, 1.6g DHA

(previous Rx included 15mg/week of methotrexate, and Enbrel)

[Guest guest]

Hi DJ;

These are really great questions. I tried to explain the

exclusion/inclusion criteria in Message #95248 (Memo from Memphis).

If you can't access the archives, then let me know and I'll re-post

it. It boils down to how much money it will cost to enter data for

each patient, and for annual maintainence thereafter for each patient

in the registry. In Message #95248 I try to go through all of the

costs, and how many patients they can include with the funda

available. If there was an unlimited supply of funds, then yes they

would be able to back many more years.

PSC Partners is contributing to the project, but the vast majority of

the funds are provided by Musette and .

This would be something to bring up with Dr. Black at the conference

in May.

Best regards,

Dave

(father of (22); PSC 07/03; UC 08/03)