Biomarkers for Early Detection of Ovarian Cancer Using Uterine Lavage
BEDOCA
Identification of Novel Biomarkers for Early Detection of Ovarian Cancer in High-risk and Normal-risk Populations Using Uterine Lavage
1 other identifier
interventional
500
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable ovarian-cancer
Started Jun 2014
Longer than P75 for not_applicable ovarian-cancer
4 active sites
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
Study Start
First participant enrolled
June 29, 2014
CompletedFirst Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 26, 2020
February 1, 2020
8.5 years
May 3, 2017
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
7 years
Secondary Outcomes (2)
Complications rate of uterine lavage procedure in high risk population
7 years
Burden of uterine lavage procedure as routine diagnostic test for high risk population
7 years
Study Arms (3)
Ovarian cancer patients
EXPERIMENTALHigh 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 COMPARATORPatients with non-malignant gynecological conditions indicating surgical procedure, either salpingo-oophorectomy, hysterectomy or hysteroscopy.
High risk population
EXPERIMENTALHealthy women with genetically high risk for developing ovarian cancer, who have not undergone risk reducing procedure.
Interventions
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 will be drawn from participants.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Rabin Medical Centercollaborator
- Meir Medical Centercollaborator
- Shaare Zedek Medical Centercollaborator
Study Sites (4)
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 49414, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Related Publications (1)
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.
PMID: 36214786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keren Levanon, MD,PhD
Sheba Medical Center
- PRINCIPAL INVESTIGATOR
Yfat Kadan, MD
Meir Medical Center
- PRINCIPAL INVESTIGATOR
Ram Eitan, MD
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 12, 2017
Study Start
June 29, 2014
Primary Completion
December 31, 2022
Study Completion
December 31, 2024
Last Updated
February 26, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share