pone.0294564.s001.pdf (111.71 kB)
SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.
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posted on 2023-11-27, 18:35 authored by Aashna Karbhari, Sherly Mosessian, Kamaxi H. Trivedi, Frank Valla Jr, Mark Jacobson, Mark J. Truty, Nandakumar G. Patnam, Diane M. Simeone, Elcin Zan, Tracy Brennan, Hongli Chen, Phillip H. Kuo, Ken Herrmann, Ajit H. GoenkaSPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.
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widespread metastatic disseminationsafety profile validationpancreatic ductal adenocarcinomanew drug applicationmeeting fda requirementslethal disease pronefibroblast activation proteincurrent study seekscurative surgical resectionprofile caf identityinitial diagnostic biopsyimproved patient outcomes60 adult treatmentresected tumor samplesbaseline pet scancohort 2 ).open label nonmediated therapy resistanceassess predictive values68 supcohort 2 patientsnat [< supgov identifier nct05262855[< suptreatment resistancephase 2cohort 1poor outcomesovercoming cafneoadjuvant therapygov identifierdiagnostic performancetumor stromatumor growthadditional petversus posttruth standardsstakeholder expectationssingle armsecondary objectivesprimary objectivenaïve patientsmitigate risksinvasive toolsinfluencing carcinogenesisimage fapfap immunohistochemistryexploratory objectivesdetecting fapdesmoplastic stromacrucial componentscompleting natcoherent strategyclinical translationcare imagingassociated fibroblasts46 pet
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