Clinical trial · Interventional
Identification and Characterization of Ovarian Cancer and Endometrial Cancer Specific Biomarkers in Vaginal Fluids
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to: 1. Identification and characterization of ovarian carcinoma well-known biomarkers, carcinoma antigen 125 (CA125) and Human epididymis protein 4 (HE4) and other potential biomarkers in vaginal fluids obtained from ovarian cancer patients. 2. Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients in comparisons to samples collected from healthy volunteers. 3. Comparison analysis of biomarkers levels in vaginal fluids vs. serum. 4. Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients diagnosed in various stages.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Ovary | Malignant Ovarian Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluid sample | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaginal fluid of healthy patient
- description
- vaginal fluid sample from healthy patients
- interventionNames
- Procedure: fluid sample
- type
- EXPERIMENTAL
- label
- Vaginal fluid of ovary cancer patients
- description
- vaginal fluid sample from patients with ovary cancer
- interventionNames
- Procedure: fluid sample
Primary outcomes (2)
- measure
- The difference in the levels of the Human Epididymis Protein 4 (HE4) measured between healthy patients and ovary cancer patients. Measuring units will be pmol/L.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ovarian carcinoma (in the "disease" arm) Exclusion Criteria: * non
References
Publications (4)
- RESULTOrfanelli 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: 10.1177/1933719113503416. Epub 2013 Sep 10. PMID 24023032
- RESULTMontagnana 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/jcla.20340. PMID 19774626
- RESULTDrapkin 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. doi: 10.1158/0008-5472.CAN-04-3924. PMID 15781627
- RESULTKim A, Ueda Y, Naka T, Enomoto T. Therapeutic strategies in epithelial ovarian cancer. J Exp Clin Cancer Res. 2012 Feb 13;31(1):14. doi: 10.1186/1756-9966-31-14. PMID 22330607