NCT01385436 - 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)

Lepej SZ, Grgic I, Poljak M, Iscic-Bes J, Skerk V, Vince DB, Dusek D, Vince A
Detection of human papillomavirus genotypes 16/18/45 by hybrid capture hybridisation genotyping probe in clinical specimens: the first report. J Clin Virol. 2007 Oct;40(2):171-2. Epub 2007 Aug 16.
Milutin Gasperov N, Sabol I, Matovina M, Spaventi S, Grce M
Detection and typing of human papillomaviruses combining different methods: polymerase chain reaction, restriction fragment length polymorphism, line probe assay and sequencing. Pathol Oncol Res. 2008 Dec;14(4):355-63. doi: 10.1007/s12253-008-9084-2. Epub 2008 Aug 28.
Poljak M, Kocjan BJ
Commercially available assays for multiplex detection of alpha human papillomaviruses. Expert Rev Anti Infect Ther. 2010 Oct;8(10):1139-62. doi: 10.1586/eri.10.104. Review.
Seme K, Lepej SZ, Lunar MM, Iscic-Bes J, Planinic A, Kocjan BJ, Vince A, Poljak M
Digene HPV Genotyping RH Test RUO: comparative evaluation with INNO-LiPA HPV Genotyping Extra Test for detection of 18 high-risk and probable high-risk human papillomavirus genotypes. J Clin Virol. 2009 Oct;46(2):176-9. doi: 10.1016/j.jcv.2009.07.017. Epub 2009 Aug 15.
Vrtacnik Bokal E, Kocjan BJ, Poljak M, Bogovac Z, Jancar N
Genomic variants of human papillomavirus genotypes 16, 18, and 33 in women with cervical cancer in Slovenia. J Obstet Gynaecol Res. 2010 Dec;36(6):1204-13. doi: 10.1111/j.1447-0756.2010.01316.x.

Pre-vaccination Distribution of Human Papillomavirus (HPV) Genotypes in Patients With High Grade Cervical Squamous Intraepithelial Lesion (HSIL) and Cervical Cancer From Croatia

Details for clinical trial NCT01385436

Clinical trial NCT01385436 - References