Ovarian CancerBEDOCANCT03150121
Biomarkers for Early Detection of Ovarian Cancer Using Uterine Lavage
A study testing Uterine lavage, Blood sample and Uterine lavage catheter in people with Ovarian Cancer and Ovarian Carcinoma, run by Sheba Medical Center at 4 sites in Israel.
Trial summary
Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific mortality, since they do not offer early enough detection of the disease. Most cases of high grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for high-risk populations (e.g., BRCA1/2 mutation… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Ovarian Carcinoma, Fallopian Tube Cancer
- What is being tested?
- Uterine lavage, Blood sample and Uterine lavage catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesIsrael
- Study dates
- 29 Jun 2014to 31 Dec 2024
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be at least 18 years of age.
- Subject must have all gynecological organs, including: vagina, cervix, uterus, fallopian tubes and ovaries.
- For the proof-of-principle cohort:
- Subject must have been evaluated for a gynecologic condition, for which the treating physician has determined that a surgical intervention is required. The surgical procedure may be either: hysterectomy, surgical hysteroscopy, or salpingo-oophorectomy.
- The eligible gynecological diagnoses include: high grade ovarian, fallopian tube or primary peritoneal carcinoma, or any non-malignant gynecologic condition.
- For the high risk cohort:
- Subject must have an increased risk for developing ovarian cancer, as determined by genetic testing for BRCA1 or BRCA2 mutations, or by family history of at least one first degree relative that has been diagnosed with high grade ovarian cancer.
Who cannot join
- Subject is pregnant or is currently attempting to conceive.
- Subject has undergone resection of the uterus, fallopian tubes or ovaries.
- Subject is unable to read, understand and sign the informed consent form.
- Subject refuses to allow access to medical records or pathology reports.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites, 4 recruiting
- Not yet recruiting
Shaare Zedek Medical Center
Jerusalem, 91031
Shunit Armon, MD, shunitarmon@gmail.com
- Recruiting
Meir Medical Center
Kfar Saba, 44281
Yfat Kadan, MD
yfat_ka@clalit.org.il
- Recruiting
Rabin Medical Center
Petah Tikva, 49414
Ram Eitan, MD, EitanR@clalit.org.il
Ariella Jakobson-Setton, MD, arielaya@clalit.org.il
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Keren Levanon, MD, PhD, +972-3-5304961, Keren.Levanon@sheba.health.gov.il
Tamar Perri, MD, +972-3-5302792, tamarperri@gmail.com
About this study
Official title: Identification of Novel Biomarkers for Early Detection of Ovarian Cancer in High-risk and Normal-risk Populations Using Uterine Lavage
Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific mortality, since they do not offer early enough detection of the disease. Most cases of high grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for high-risk populations (e.g., BRCA1/2 mutation carriers) is to undergo risk-reducing bilateral salpingo-oophorectomy (RRBSO) around the age of 40. The aims of this trial are: (1) to identify novel early-stage disease biomarkers using liquid biopsies obtained through uterine lavage, and (2) to optimize the technique a of uterine lavage and the processing of the samples for ultimate implementation as a routine diagnostic test for high risk populations.
Read the detailed description
Brief Summary:
Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific mortality, since they do not offer early enough detection of the disease. Most cases of high grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for high-risk populations (e.g., BRCA1/2 mutation carriers) is to undergo risk-reducing bilateral salpingo-oophorectomy (RRBSO) around the age of 40. The aims of this trial are: (1) to identify novel early-stage disease biomarkers using liquid biopsies obtained through uterine lavage, and (2) to optimize the technique a of uterine lavage and the processing of the samples for ultimate implementation as a routine diagnostic test for high risk populations.
The end point of the study is sensitivity and specificity of a liquid biopsy test based on uterine lavage for detection of ovarian cancer.
The study enrolls two cohorts:
- Proof-of-principle cohort - patients with either established ovarian cancer or other, non-malignant, gynecological conditions.
- High risk cohort - healthy women at genetically high-risk for ovarian cancer who have not undergone RRBSO.
Inclusion criteria include age over 18, ability to read, understand and sign informed consent form, and planned surgical procedure with general anesthesia (for the proof-of-principle cohort), or planned regular gynecological examination due to high-risk for developing ovarian cancer (high risk cohort).
Exclusion criteria include pregnancy or current attempts to conceive, any prior condition that precludes washing of the entire fallopian tubes.
Patients will provide signed informed consent and will undergo uterine lavage which will be performed by a surgeon before surgery, after induction of anesthesia (proof-of-principle cohort), or by a gynecologist during gynecological examination in an office setting (high risk cohort). Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved. 5-10mL of blood is also collected from each participant. Patients who have undergone the procedure without anesthesia are requested to complete a pain and stress score questionnaire. All patients are asked to allow access of their medical records and pathology reports from past, present and future gynecologic surgeries.
The uterine lavage liquid biopsy samples are centrifuged to eliminate cells and cell debris. Supernatants were aliquoted within 6 hours from the procedure. Microvesicles, total RNA and DNA are isolated according to previously published protocols.
The samples of the proof-of-principle cohort will be used to define an optimized set of assays, measuring either protein-based or nucleic acid-based biomarkers.
The samples of the high risk cohort will be used to test the sensitivity and specificity of the previously defined biomarkers, and to evaluate confounding factors that may affect the accuracy of the test, such as menopausal status and breast cancer endocrine therapy. Each participant will be asked to consent to uterine lavage procedure on subsequent follow-up visits.
- Conditions
- Ovarian Cancer, Ovarian Carcinoma, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Serous Cystadenocarcinoma
- Being tested
- Uterine lavage, Blood sample, Uterine lavage catheter
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Cystadenocarcinoma, Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine lavageProcedure or surgery
Also called Tubo-uterine lavage
Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved.
Blood sampleProcedure or surgery
5-10mL of blood will be drawn from participants.
Uterine lavage catheterDevice
Also called Intrauterine insemination catheter
Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients | Experimental | High grade ovarian/fallopian tube/primary peritoneal carcinoma patients with current active disease, at any stage and histological type, who have not yet undergone debulking surgery. Receives: Procedure: Uterine lavage; Procedure: Blood sample; Device: Uterine lavage catheter |
| Non-malignant controls | Active comparator | Patients with non-malignant gynecological conditions indicating surgical procedure, either salpingo-oophorectomy, hysterectomy or hysteroscopy. Receives: Procedure: Uterine lavage; Procedure: Blood sample; Device: Uterine lavage catheter |
| High risk population | Experimental | Healthy women with genetically high risk for developing ovarian cancer, who have not undergone risk reducing procedure. Receives: Procedure: Uterine lavage; Procedure: Blood sample; Device: Uterine lavage catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of uterine lavage-based biomarkers to detect early stage ovarian cancer
Sensitivity and specificity of proteomic and genomic biomarkers measured in uterine lavage liquid biopsies. The samples will be analyzed in a blinded fashion. The pathological data of the patients will be reviewed and the sensitivity/specificity of each biomarker will be calculated
Measured: 7 years
Secondary outcomes (2)
Complications rate of uterine lavage procedure in high risk population
Assessment of complications rate based on patient's questionnaire and medical records
Measured: 7 years
Burden of uterine lavage procedure as routine diagnostic test for high risk population
Assessment of cost-effectiveness of uterine lavage-based diagnostic test for high risk population, including direct and indirect costs
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start29 Jun 2014
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Rabin Medical Center, Meir Medical Center, Shaare Zedek Medical Center
- Responsible party
- Sponsor
- Investigators
- Keren Levanon, MD,PhD, Principal investigator, Sheba Medical CenterYfat Kadan, MD, Principal investigator, Meir Medical CenterRam Eitan, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150121
- Sponsor's protocol ID
- SHEBA-13-0930-KL-CTIL
- Acronym
- BEDOCA
- Status last verified
- Feb 2020
- First submitted
- 3 May 2017
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bahar-Shany K, Barnabas GD, Deutsch L, Deutsch N, Glick-Saar E, Dominissini D, Sapoznik S, Helpman L, Perri T, Blecher A, Katz G, Yagel I, Rosenblatt O, Shai D, Brandt B, Meyer R, Mohr-Sasson A, Volodarsky-Perel A, Zilberman I, Armon S, Jakobson-Setton A, Eitan R, Kadan Y, Beiner M, Josephy D, Brodsky M, Friedman E, Anafi L, Molchanov Y, Korach J, Geiger T, Levanon K. Proteomic signature for detection of high-grade ovarian cancer in germline BRCA mutation carriers. Int J Cancer. 2023 Feb 15;152(4):781-793. doi: 10.1002/ijc.34318. Epub 2022 Oct 23.
PubMed 36214786
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Novel Biomarkers for Early Detection of Ovarian Cancer in High-risk and Normal-risk Populations Using Uterine Lavage
- ClinicalTrials.gov ID
- NCT03150121
- Acronym / sponsor ID
- BEDOCA / SHEBA-13-0930-KL-CTIL
- Conditions
- Ovarian Cancer, Ovarian Carcinoma, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Serous Cystadenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Rabin Medical Center, Meir Medical Center, Shaare Zedek Medical Center
- Study start
- 29 Jun 2014 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 May 2017 (actual)
- 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.
Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific mortality, since they do not offer early enough detection of the disease. Most cases of high grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for high-risk populations (e.g., BRCA1/2 mutation carriers) is to undergo risk-reducing bilateral salpingo-oophorectomy (RRBSO) around the age of 40. The aims of this trial are: (1) to identify novel early-stage disease biomarkers using liquid biopsies obtained through uterine lavage, and (2) to optimize the technique a of uterine lavage and the processing of the samples for ultimate implementation as a routine diagnostic test for high risk populations.
Detailed description
Brief Summary:
Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific mortality, since they do not offer early enough detection of the disease. Most cases of high grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for high-risk populations (e.g., BRCA1/2 mutation carriers) is to undergo risk-reducing bilateral salpingo-oophorectomy (RRBSO) around the age of 40. The aims of this trial are: (1) to identify novel early-stage disease biomarkers using liquid biopsies obtained through uterine lavage, and (2) to optimize the technique a of uterine lavage and the processing of the samples for ultimate implementation as a routine diagnostic test for high risk populations.
The end point of the study is sensitivity and specificity of a liquid biopsy test based on uterine lavage for detection of ovarian cancer.
The study enrolls two cohorts:
- Proof-of-principle cohort - patients with either established ovarian cancer or other, non-malignant, gynecological conditions.
- High risk cohort - healthy women at genetically high-risk for ovarian cancer who have not undergone RRBSO.
Inclusion criteria include age over 18, ability to read, understand and sign informed consent form, and planned surgical procedure with general anesthesia (for the proof-of-principle cohort), or planned regular gynecological examination due to high-risk for developing ovarian cancer (high risk cohort).
Exclusion criteria include pregnancy or current attempts to conceive, any prior condition that precludes washing of the entire fallopian tubes.
Patients will provide signed informed consent and will undergo uterine lavage which will be performed by a surgeon before surgery, after induction of anesthesia (proof-of-principle cohort), or by a gynecologist during gynecological examination in an office setting (high risk cohort). Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved. 5-10mL of blood is also collected from each participant. Patients who have undergone the procedure without anesthesia are requested to complete a pain and stress score questionnaire. All patients are asked to allow access of their medical records and pathology reports from past, present and future gynecologic surgeries.
The uterine lavage liquid biopsy samples are centrifuged to eliminate cells and cell debris. Supernatants were aliquoted within 6 hours from the procedure. Microvesicles, total RNA and DNA are isolated according to previously published protocols.
The samples of the proof-of-principle cohort will be used to define an optimized set of assays, measuring either protein-based or nucleic acid-based biomarkers.
The samples of the high risk cohort will be used to test the sensitivity and specificity of the previously defined biomarkers, and to evaluate confounding factors that may affect the accuracy of the test, such as menopausal status and breast cancer endocrine therapy. Each participant will be asked to consent to uterine lavage procedure on subsequent follow-up visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients | Experimental | Procedure: Uterine lavage, Procedure: Blood sample, Device: Uterine lavage catheterHigh grade ovarian/fallopian tube/primary peritoneal carcinoma patients with current active disease, at any stage and histological type, who have not yet undergone debulking surgery. |
| Non-malignant controls | Active comparator | Procedure: Uterine lavage, Procedure: Blood sample, Device: Uterine lavage catheterPatients with non-malignant gynecological conditions indicating surgical procedure, either salpingo-oophorectomy, hysterectomy or hysteroscopy. |
| High risk population | Experimental | Procedure: Uterine lavage, Procedure: Blood sample, Device: Uterine lavage catheterHealthy women with genetically high risk for developing ovarian cancer, who have not undergone risk reducing procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be at least 18 years of age.
- Subject must have all gynecological organs, including: vagina, cervix, uterus, fallopian tubes and ovaries.
- For the proof-of-principle cohort:
- For the high risk cohort:
Key exclusion criteria (4 listed)
- Subject is pregnant or is currently attempting to conceive.
- Subject has undergone resection of the uterus, fallopian tubes or ovaries.
- Subject is unable to read, understand and sign the informed consent form.
- Subject refuses to allow access to medical records or pathology reports.
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 |
|---|---|---|
| Uterine lavageAlso: Tubo-uterine lavageUterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved. | Procedure or surgery | High risk population, Non-malignant controls, Ovarian cancer patients |
| Blood sample5-10mL of blood will be drawn from participants. | Procedure or surgery | High risk population, Non-malignant controls, Ovarian cancer patients |
| Uterine lavage catheterAlso: Intrauterine insemination catheterUterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved. | Device | High risk population, Non-malignant controls, Ovarian cancer patients |
Primary outcome
Ability of uterine lavage-based biomarkers to detect early stage ovarian cancer
Time frame: 7 years
Sensitivity and specificity of proteomic and genomic biomarkers measured in uterine lavage liquid biopsies. The samples will be analyzed in a blinded fashion. The pathological data of the patients will be reviewed and the sensitivity/specificity of each biomarker will be calculated
2 secondary outcomes
Complications rate of uterine lavage procedure in high risk population
Time frame: 7 years
Burden of uterine lavage procedure as routine diagnostic test for high risk population
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 36214786Bahar-Shany K, Barnabas GD, Deutsch L, Deutsch N, Glick-Saar E, Dominissini D, Sapoznik S, Helpman L, Perri T, Blecher A, Katz G, Yagel I, Rosenblatt O, Shai D, Brandt B, Meyer R, Mohr-Sasson A, Volodarsky-Perel A, Zilberman I, Armon S, Jakobson-Setton A, Eitan R, Kadan Y, Beiner M, Josephy D, Brodsky M, Friedman E, Anafi L, Molchanov Y, Korach J, Geiger T, Levanon K. Proteomic signature for detection of high-grade ovarian cancer in germline BRCA mutation carriers. Int J Cancer. 2023 Feb 15;152(4):781-793. doi: 10.1002/ijc.34318. Epub 2022 Oct 23.
- 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.
Keren Levanon, MD,PhD principal investigator
Sheba Medical Center
Yfat Kadan, MD principal investigator
Meir Medical Center
Ram Eitan, MD principal investigator
Rabin Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine lavage, Blood sample and Uterine lavage catheter in people with Ovarian Cancer and Ovarian Carcinoma, run by Sheba Medical Center at 4 sites in Israel.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keren Levanon, MD, PhD (+972-3-5304961, Keren.Levanon@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of uterine lavage-based biomarkers to detect early stage ovarian cancer (time frame: 7 years). 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 NCT03150121, which also lists 1 linked publication.
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 26 Feb 2020.