NCT00341016 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chumak VV, Romanenko AY, Voillequé PG, Bakhanova EV, Gudzenko N, Hatch M, Zablotska LB, Golovanov IA, Luckyanov NK, Sholom SV, Kryuchkov VP, Bouville A
The Ukrainian-American study of leukemia and related disorders among Chornobyl cleanup workers from Ukraine: II. Estimation of bone marrow doses. Radiat Res. 2008 Dec;170(6):698-710. doi: 10.1667/RR1403.1.
Gudzenko N, Hatch M, Bazyka D, Dyagil I, Reiss RF, Brenner A, Chumak V, Babkina N, Zablotska LB, Mabuchi K
Non-radiation risk factors for leukemia: A case-control study among chornobyl cleanup workers in Ukraine. Environ Res. 2015 Oct;142:72-6. doi: 10.1016/j.envres.2015.06.019. Epub 2015 Jun 24.
Zablotska LB, Bazyka D, Lubin JH, Gudzenko N, Little MP, Hatch M, Finch S, Dyagil I, Reiss RF, Chumak VV, Bouville A, Drozdovitch V, Kryuchkov VP, Golovanov I, Bakhanova E, Babkina N, Lubarets T, Bebeshko V, Romanenko A, Mabuchi K
Radiation and the risk of chronic lymphocytic and other leukemias among chornobyl cleanup workers. Environ Health Perspect. 2013 Jan;121(1):59-65. doi: 10.1289/ehp.1204996. Epub 2012 Nov 8.

Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident

Clinical trial NCT00341016 - References