Hi
I was reading the paper that describes the DFCI study and there were 700 patients divided exactly in 2 arms. In the validation set we are only given 380. How were these selected? Are they mostly from 1 arm or were they randomly chosen?
thanks
DA
Created by exquirentibus veritatem exquirentibus Thanks for the clarification Hi,
The NEJM paper refers to the French side of the trial. The US side of the trial (dubbed DETERMINATION trial) is covered here:
http://www.dana-farber.org/newsroom/news-releases/2017/stem-cell-transplant-plus-novel-drug-combination-lengthens-control-of-multiple-myeloma-versus-novel-drugs-alone--trial-finds--but-with-no-difference-in-overall-survival/
"Finally, the ongoing parallel US study of the IFM/DFCI 2009 project (the so-called DETERMINATION trial), which is now almost fully enrolled with 720 patients, complements this work by evaluating the impact of maintenance until progression, versus one year as was assessed in the French protocol. Results from this trial, which is led by the Dana-Farber team, are expected within the next one to two years."
To be clear, our "DFCI" patients are coming from this parallel US-based DETERMINATION study that follows the same French protocol you linked to.
Fadi surprisingly in the paper describing the results
http://www.nejm.org/doi/full/10.1056/NEJMoa1611750#t=articleTop
they claim ALL patients come from Europe and mostly from France (98%).
Also in the clinical trial website it says that they are all from France.
https://clinicaltrials.gov/ct2/show/study/NCT01191060?show_locs=Y#locn
is this the right study ID number?
Hi,
That trial (https://clinicaltrials.gov/ct2/show/NCT01191060) has 2 different sites: DFCI in US and University Hospital, Toulouse in France. The DFCI samples utilized in the validation are all coming from the DFCI site and have both arms from the clinical trial.
Best,
Fadi i see.. i got why my model was consistently lower than baseline. thanks so much! Here is the trial info:
https://clinicaltrials.gov/ct2/show/NCT01191060
which paper??!!