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

Cancer of Ovary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02704650
• Other study ID #: Shachar-1
• Status: Withdrawn
• Phase: N/A
• First received: February 11, 2016
• Last updated: April 26, 2017
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Initially, twenty vaginal fluid samples will be collected from ovarian cancer patients diagnosed with epithelial ovarian carcinoma at advanced diagnosis stage.

The samples will be used to identify specific biomarkers as describe above. Biomarkers levels will be calibrated compared to their vaginal fluids obtained from healthy volunteers. In addition, five milliliters of venous blood will be collected from same patients in order to compare biomarkers vaginal fluids levels vs serum levels. All patients will sign a consent form which approve that their vaginal fluid samples will be utilized for research according to Helsinki approval.

At the second phase of the research, additional twenty vaginal fluids samples will be collected from patients diagnosed at different stages (five samples from each of main stages 1-4). Sample will be used to calibrate biomarkers levels in various diagnosis stages and will be compare to serum levels from venous blood samples which will be also collected from the same patients.

All patients will sign a consent form following explanation on research goals. Patient will be notified that participation in this research will have no implication on medical treatment plan.

Note that in all research phases there will be no returning of samples to the patients, all identification and characterization procedures will be performed in vitro for research properties only.

Methodology

• Collecting vaginal fluids samples from ovarian cancer patients. Vaginal fluids (at least 400µl, the investigators wish to have 1000 µl) will be collected during surgery or during routine physical examination using specific applicator/cotton swab/syringe. Samples will be shipped to GinaLife Diagnostics laboratory for analysis. In addition, on the day of vaginal fluids collection 5 ml of peripheral blood samples will be drawn from each volunteer.

• Analyzing specific biomarkers in samples. Vaginal fluids will be analyzed using commercial enzyme-linked immunosorbent assay (ELISA) kits to determine the presence and the concentrations of various proteins. In addition, western blot analysis will be used in order to confirm ELISA assay results. Specific nucleic acid will be determine using common molecular methods such as Reverse transcription polymerase chain reaction (RT-PCR) etc.

• Data analysis

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ovarian carcinoma (in the "disease" arm)

Exclusion Criteria:

• non

Related Conditions & MeSH terms

• Cancer of Ovary
• Endometrial Neoplasms
• Ovarian Neoplasms

Intervention

Procedure:
• fluid sample
taking a vaginal fluid sample

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center	GinaLife Diagnostics LTD.

References & Publications (4)

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year
Primary	The difference in the levels of the glycoprotein CA-125 between healthy patients and ovary cancer patients. The measuring units will be U/mL.		1 year