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-   -   Joined blood trial & Serum test thoughts (https://her2support.org/vbulletin/showthread.php?t=14225)

Steph N 10-14-2004 03:06 PM

Hi everyone -
A couple of things to report after my clinic visits this week.
I have joined a trial that is an attempt to see if looking at the Keratin 19 and other related molecular markers in blood samples, using a new counting method, will be a predictor of breast abnormalities and disease. The original idea was to follow a patient through the ititial disease and treatment then for 3 to 6 years following. I was first presented with this trial at the outset of my chemo in Dec 2000. Then the trial went on the back burner to fine tune the counting method. The study nurse caught up with me this week and I agreed to participate even though I am NED and on maintenance - they want people like this and Her2 pos to follow.
My doctor was fine with this, saying there would be little direct benefit for me, but I may contribute to a useful body of data. Nothing has yet been written up on this trial, but the study nurse says there has been some exciting recent data coming out of the lab.

REgarding the Bayer Serum HER-2/neu Oncoprotein Test, my med onc did not see it as anything that would be useful for me. He first pointed out that there is some question as to the accuracy of this rather pricy test for those already on Herceptin. He then said that since I have had such long-standing steady results from the CA 27-29 (from 19 - 24) and CEA (from .9 to 2.5) markers that adding in another result would be virtually meaningless at this time.
I am scheduled for all scans in January including annual brain MRI. He did not hesitate to add that one in - it will be my third one.

Cathy W 10-15-2004 03:19 AM

From what I have read, the serum test is valuable in that it can detect progression of disease before the regular diagnostic tests do.

STeph N 10-15-2004 03:44 AM

Cathy said: "From what I have read, the serum test is valuable in that it can detect progression of disease before the regular diagnostic tests do."

That was also my understanding - but there is some holdup from the oncolgy community is wanting to use it. This test was cleared in 2000 by FDA. Worldwide availablity for use with the ADVIA Centaur immuno assay system in 2003. Perhaps the insurance companies don't want to cover it or the accuracy is somehow questionable (as for patients already on Herceptin).
Perhaps this is a question for Joe or Christine to put to their experts.
Everyone, please ask your med onc about this one so we can perhaps get some concensus.

AlaskaAngel 10-15-2004 03:45 AM

Can you give me the name of the clinical trial? I couldn't find it on clinicaltrials.gov.


Lolly 10-15-2004 01:33 PM

Hi Steph, this sounds very interesting and exciting, and will be following your posts on this very closely...

Thanks for the valuable info, once again on the cutting edge up there in the misty rainforest :)

Love, Lolly


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