NCT02704650 - 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)

Drapkin R, von Horsten HH, Lin Y, Mok SC, Crum CP, Welch WR, Hecht JL
Human epididymis protein 4 (HE4) is a secreted glycoprotein that is overexpressed by serous and endometrioid ovarian carcinomas. Cancer Res. 2005 Mar 15;65(6):2162-9.
Kim A, Ueda Y, Naka T, Enomoto T
Therapeutic strategies in epithelial ovarian cancer. J Exp Clin Cancer Res. 2012 Feb 13;31:14. doi: 10.1186/1756-9966-31-14. Review.
Montagnana M, Lippi G, Ruzzenente O, Bresciani V, Danese E, Scevarolli S, Salvagno GL, Giudici S, Franchi M, Guidi GC
The utility of serum human epididymis protein 4 (HE4) in patients with a pelvic mass. J Clin Lab Anal. 2009;23(5):331-5. doi: 10.1002/jc
Orfanelli T, Jayaram A, Doulaveris G, Forney LJ, Ledger WJ, Witkin SS
Human epididymis protein 4 and secretory leukocyte protease inhibitor in vaginal fluid: relation to vaginal components and bacterial composition. Reprod Sci. 2014 Apr;21(4):538-42. doi

Identification and Characterization of Ovarian Cancer and Endometrial Cancer Specific Biomarkers in Vaginal Fluids

Clinical trial NCT02704650 - References