Cancer of OvaryNCT02704650
Identification and Characterization of Ovarian Cancer and Endometrial Cancer Specific Biomarkers in Vaginal Fluids
A study testing fluid sample in people with Cancer of Ovary, run by Shaare Zedek Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer of Ovary
- What is being tested?
- fluid sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ovarian carcinoma (in the "disease" arm)
Who cannot join
- non
About this study
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.
Read the 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
- Conditions
- Cancer of Ovary
- Being tested
- fluid sample
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid sampleProcedure or surgery
taking a vaginal fluid sample
| Study group | Role | What they receive |
|---|---|---|
| Vaginal fluid of healthy patient | Experimental | vaginal fluid sample from healthy patients Receives: Procedure: fluid sample |
| Vaginal fluid of ovary cancer patients | Experimental | vaginal fluid sample from patients with ovary cancer Receives: Procedure: fluid sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer of OvaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gina-Life Diagnostics ltd.
- Responsible party
- Principal investigator, Shachar Finci, Shaare Zedek Medical Center
- Investigators
- Shachar Finci, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704650
- Sponsor's protocol ID
- Shachar-1
- Status last verified
- Apr 2017
- First submitted
- 11 Feb 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24023032Montagnana 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.
PubMed 19774626Drapkin 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.
PubMed 15781627Kim 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.
PubMed 22330607
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of Ovarian Cancer and Endometrial Cancer Specific Biomarkers in Vaginal Fluids
- ClinicalTrials.gov ID
- NCT02704650
- Acronym / sponsor ID
- Shachar-1
- Conditions
- Cancer of Ovary
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Gina-Life Diagnostics ltd.
- Study start
- May 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal fluid of healthy patient | Experimental | Procedure: fluid samplevaginal fluid sample from healthy patients |
| Vaginal fluid of ovary cancer patients | Experimental | Procedure: fluid samplevaginal fluid sample from patients with ovary cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ovarian carcinoma (in the "disease" arm)
Key exclusion criteria (1 listed)
- non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluid sampletaking a vaginal fluid sample | Procedure or surgery | Vaginal fluid of healthy patient, Vaginal fluid of ovary cancer patients |
Primary outcome
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Results publication: PubMed 24023032Orfanelli 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.
- Results publication: PubMed 19774626Montagnana 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.
- Results publication: PubMed 15781627Drapkin 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.
- Results publication: PubMed 22330607Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shachar Finci, MD principal investigator
Shaare Zedek Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing fluid sample in people with Cancer of Ovary, run by Shaare Zedek Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704650, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.