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Biomarkers for Early Detection of Ovarian Cancer Using Uterine Lavage (BEDOCA)

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ClinicalTrials.gov Identifier: NCT03150121
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
Rabin Medical Center
Meir Medical Center
Shaare Zedek Medical Center
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Ovarian Carcinoma Fallopian Tube Cancer Primary Peritoneal Carcinoma Serous Cystadenocarcinoma Procedure: Uterine lavage Procedure: Blood sample Device: Uterine lavage catheter Not Applicable

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:

  1. Proof-of-principle cohort - patients with either established ovarian cancer or other, non-malignant, gynecological conditions.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification of Novel Biomarkers for Early Detection of Ovarian Cancer in High-risk and Normal-risk Populations Using Uterine Lavage
Actual Study Start Date : June 29, 2014
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Ovarian cancer patients
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.
Procedure: 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.
Other Name: Tubo-uterine lavage

Procedure: Blood sample
5-10mL of blood will be drawn from participants.

Device: Uterine lavage 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.
Other Name: Intrauterine insemination catheter

Active Comparator: Non-malignant controls
Patients with non-malignant gynecological conditions indicating surgical procedure, either salpingo-oophorectomy, hysterectomy or hysteroscopy.
Procedure: 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.
Other Name: Tubo-uterine lavage

Procedure: Blood sample
5-10mL of blood will be drawn from participants.

Device: Uterine lavage 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.
Other Name: Intrauterine insemination catheter

Experimental: High risk population
Healthy women with genetically high risk for developing ovarian cancer, who have not undergone risk reducing procedure.
Procedure: 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.
Other Name: Tubo-uterine lavage

Procedure: Blood sample
5-10mL of blood will be drawn from participants.

Device: Uterine lavage 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.
Other Name: Intrauterine insemination catheter




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Complications rate of uterine lavage procedure in high risk population [ Time Frame: 7 years ]
    Assessment of complications rate based on patient's questionnaire and medical records

  2. Burden of uterine lavage procedure as routine diagnostic test for high risk population [ Time Frame: 7 years ]
    Assessment of cost-effectiveness of uterine lavage-based diagnostic test for high risk population, including direct and indirect costs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Relevant only for female participants
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03150121


Contacts
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Contact: Keren Levanon, MD, PhD +972-3-5304961 Keren.Levanon@sheba.health.gov.il

Locations
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Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Shunit Armon, MD       shunitarmon@gmail.com   
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Yfat Kadan, MD         
Contact       yfat_ka@clalit.org.il   
Rabin Medical Center Recruiting
Petaẖ Tiqwa, Israel, 49414
Contact: Ram Eitan, MD       EitanR@clalit.org.il   
Contact: Ariella Jakobson-Setton, MD       arielaya@clalit.org.il   
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Keren Levanon, MD, PhD    +972-3-5304961    Keren.Levanon@sheba.health.gov.il   
Contact: Tamar Perri, MD    +972-3-5302792    tamarperri@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Rabin Medical Center
Meir Medical Center
Shaare Zedek Medical Center
Investigators
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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
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03150121    
Other Study ID Numbers: SHEBA-13-0930-KL-CTIL
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Cystadenocarcinoma
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous