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

Sponsor

Shaare Zedek Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02704650

Collaborator

Gina-Life Diagnostics ltd. (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to:

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.
Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients in comparisons to samples collected from healthy volunteers.
Comparison analysis of biomarkers levels in vaginal fluids vs. serum.
Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients diagnosed in various stages.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Ovary	Procedure: fluid sample	N/A

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal fluid of healthy patient vaginal fluid sample from healthy patients	Procedure: fluid sample taking a vaginal fluid sample
Experimental: Vaginal fluid of ovary cancer patients vaginal fluid sample from patients with ovary cancer	Procedure: fluid sample taking a vaginal fluid sample

Arm

Intervention/Treatment

Experimental: Vaginal fluid of healthy patient

vaginal fluid sample from healthy patients

Procedure: fluid sample

taking a vaginal fluid sample

Experimental: Vaginal fluid of ovary cancer patients

vaginal fluid sample from patients with ovary cancer

Procedure: fluid sample

taking a vaginal fluid sample

Outcome Measures

Primary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ovarian carcinoma (in the "disease" arm)

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shaare Zedek Medical Center
Gina-Life Diagnostics ltd.

Investigators

Principal Investigator: Shachar Finci, MD, Shaare Zedek Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shachar Finci, Principal Investigator, Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT02704650

Other Study ID Numbers:

Shachar-1

First Posted:

Mar 10, 2016

Last Update Posted:

Apr 27, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Ovarian Neoplasms

Endometrial Neoplasms

Study Results

No Results Posted as of Apr 27, 2017