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Trial record 85 of 415 for:    shaare zedek

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

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ClinicalTrials.gov Identifier: NCT02704650
Recruitment Status : Withdrawn
First Posted : March 10, 2016
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Gina-Life Diagnostics LTD
Information provided by (Responsible Party):
Shachar Finci, Shaare Zedek Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer of Ovary Procedure: fluid sample Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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




Primary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]
  2. The difference in the levels of the glycoprotein CA-125 between healthy patients and ovary cancer patients. The measuring units will be U/mL. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ovarian carcinoma (in the "disease" arm)

Exclusion Criteria:

  • non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704650


Sponsors and Collaborators
Shaare Zedek Medical Center
Gina-Life Diagnostics LTD
Investigators
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Principal Investigator: Shachar Finci, MD Shaare Zedek Medical Center

Publications of Results:
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Responsible Party: Shachar Finci, Principal Investigator, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02704650     History of Changes
Other Study ID Numbers: Shachar-1
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Ovarian Neoplasms
Endometrial Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases