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Old 08-14-2008, 05:59 PM   #1
gdpawel
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Individualized Online Clinical Trial Protocol Version 1.0

The traditional meaning of Health 2.0, according to Jane Sarasohn-Kahn's "Wisdom of Patients" has been the use of social software and light-weight tools to promote collaboration between patients, their caregivers, medical professionals and other stakeholders in health.

http://www.chcf.org/topics/chronicdi...?itemID=133631

An example of this in cancer medicine is Individualized Online Clinical Trial Protocol Version 1.0 by the Weisenthal Cancer Group, a Phase II evaluation of individualized cancer treatment with traditional cytotoxic chemotherapy, targeted anti-kinase drugs and anti-angiogenic agents.

With most clinical trials, investigators never give out information as to how people are doing. Most trials are failures with respect to actually improving things. The world doesn't find out what happen until after a hundred or 500 or 2,000 patients are treated and then only 24 hours before the New England Journal of Medicine publication date.

Individualized Online Clinical Trial Protocol Version 1.0 is a totally transparent clinical trial. Every patient who decides to enter a study should know what happened to previous patients. Patients are treated in real time, on the Internet, with the whole world watching to see how they do. It includes weekly progress reports, and if individual patients want, their own blogs as to how they are doing.

Stages have been implemented for a rather innovative clinical trial with cell culture assays, "real time" on the Internet. The purpose of the study is to show that cell culture assay technologies for "targeted" agents really do work. The short-term future of cancer therapeutics is combinations of "targeted" agents.

http://weisenthalcancer.com:80/Study%20Pages/TrialHome.htm

They are not "marketing" the test beyond the confines of a clinical trial, which will be the most transparent clinical trial in the history of oncology, as all results are going to be reported, in real time, on a week by week, patient by patient basis, on the website.

Call or e-mail Weisenthal Cancer Group and ask to speak with Connie Rueff, the study coordinator. She will answer any questions you may have and will help you to determine if you are a candidate for entry. (714) 596-2100 or connie@weisenthalcancer.com

About the AngioRx Assay in breast cancer:

ER and PR tests in breast cancer, which detect only VEGF expression, or even overexpression, are valuable not because they measure expression of estrogen and progesterone but rather because they detect (and supposedly measure) the ER and PR receptors in the nucleus. The presence of positive IHC staining of such receptors in at least 10% of nuclei implies that the tumor is hormonally dependent and that, therefore, depriving the cells of the hormone will kill them or retards their growth.

Unlike a test for the presence of receptors to a specific antigen, which only "implies" dependence upon that antigen, an AngioRx assay is functional in that it actually assesses the direct or indirect effect of the drug upon the cell, whether it is a tumor cell or an endothelial cell. VEGF just happens to be one molecule which has been implicated in the process but there may be more.

If it were the only protein involved, then one would expect that VEGF expression would correlate with Avastin activity 100% of the time but it actually does so only about 20% of the time. The AngioRx assay doesn't just focus on VEGF or any one protein or mechanism. Whether it's VEGF alone (unlikely) or in combination with other proteins and other mechanical factors, the assay works by assessing the net effect of all those factors.
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