NCT02704650

Brief Summary

The purpose of this study is to:

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

February 11, 2016

Last Update Submit

April 26, 2017

Conditions

Cancer of Ovary

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Vaginal fluid of healthy patient

EXPERIMENTAL

vaginal fluid sample from healthy patients

Procedure: fluid sample

Vaginal fluid of ovary cancer patients

EXPERIMENTAL

vaginal fluid sample from patients with ovary cancer

Procedure: fluid sample

Interventions

fluid samplePROCEDURE

taking a vaginal fluid sample

Vaginal fluid of healthy patientVaginal fluid of ovary cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ovarian carcinoma (in the "disease" arm)

You may not qualify if:

  • non

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 10.1177/1933719113503416. Epub 2013 Sep 10.

    PMID: 24023032RESULT

  • 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/jcla.20340.

    PMID: 19774626RESULT

  • 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. doi: 10.1158/0008-5472.CAN-04-3924.

    PMID: 15781627RESULT

  • Kim 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: 22330607RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Shachar Finci, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2016

First Posted

March 10, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share