Study of Surrogacy Validation of Th1, Th2 in Long-Term Skin Effects of Exposure to Mustard Gas

Jalaee, Shohreh; Faghihzadeh, Soghrat; Ghazanfari, Tuba; Eskandari, Farzad; Yaraee, Roya; Moeen, Athar; Davoud, Sayed Masoud; Souroush, Mohammadreza; Fouroutan, Abbas; Naghizadeh, Mohammad Mahdi

Study of Surrogacy Validation of Th1, Th2 in Long-Term Skin Effects of Exposure to Mustard Gas

Authors

shohreh jalaee

soghrat faghihzadeh

tuba ghazanfari

farzad eskandari

roya yaraee

athar moeen

sayed masoud davoud

mohammadreza souroush

abbas fouroutan

mohammad mahdi naghizadeh

Abstract

Background & Objective : We study Surrogacy validation of Th1 and Th2, when the true endpoint is Long-term Skin Effects of Exposure to Mustard Gas based on “Martyrs and Veterans Affair” assignment. Materials & Methods : This study is a part of Sardasht-Iran cohort study. 327 chemical victims of sulfur mustard from Sardasht and 128 controlled, totally 500 persons, are studied. Results : Trial-Level surrogacy validation of “IL2 Mitogen, IFN-g Mitogen-Nill, IFN-g Mitogen, IL2 Mitogen - Nill” are more than %80. Individual –Level surrogacy of these factors are not enough Conclusion : Based on our analysis, At the trial-level, we can expect that effects of Exposure to Mustard Gas on skin in Long time (based on “Martyrs and Veterans Affair” assignment) be translated into effects of Exposure to Mustard Gas on each of “IL2 Mitogen, IFN-g Mitogen - Nill, IFN-g Mitogen, IL2 Mitogen - Nill” factors, with these factors being easier to interpret clinically. At the individual-level surrogacy we don’t find any relationship between the two endpoints, conditioning upon Mustard exposure

Keywords

Surrogate endpoints

Individual-level validity

Chemical victims

Bayes factor

Mustard gas

Cytokine Th1

Th2