Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer

NCT04794322 | Recruiting FDA Device

• 3 other identifiers: 20-4505U01CA152990U2CCA271871
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 6

Brief Summary

The study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine whether the participant had ovarian cancer or a benign disease of the ovaries. The tests of the washings and the blood will be examined to see how much the participants with ovarian cancer can be separated from the participants with a benign ovarian disease by the tests. Small amounts from the washing and the blood samples will be sent to four sites for analysis. Statistical analyses of these data will compare tumor DNA found in the washing of the uterus with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find tests that are mostly positive for cases of ovarian cancer and mostly negative for patients with benign disease. It is hoped that if the tests work for participants with symptoms of the disease that these tests will also work when testing women who have no symptoms. A new study would be needed to see if the tests worked in this situation. If the tests work, this could lead to increasing the number of cases detected in early stage disease and decreasing the number of cases detected in late stage disease. If this change in late stage is large, it will likely reduce deaths due to ovarian cancer.

Conditions

Ovarian Neoplasms; Ovarian Epithelial Carcinoma; Fallopian Tube Neoplasms; High Grade Ovarian Serous Adenocarcinoma; Stage I Ovarian Cancer; Stage II Ovarian Cancer; Stage III Ovarian Cancer AJCC v8; Stage IIIA Ovarian Cancer AJCC v8; Stage IIIA1 Ovarian Cancer AJCC v8; Stage IIIA2 Ovarian Cancer AJCC v8; Stage IIIB Ovarian Cancer AJCC v8; Stage IIIC Ovarian Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IVA Ovarian Cancer AJCC v8; Stage IVB Ovarian Cancer AJCC v8

Keywords

Uterine Lavage; Tumor DNA; Serum proteins; Ovarian neoplasms; Ovarian epithelial carcinoma; Ovarian cancer; Ovarian epithelial cancer; Neoplasms; Ovarian diseases; Early detection

Outcome Measures

Primary Outcomes (1)

• Genomic biomarkers assessing mutations and methylation of tumor DNA, and protein biomarkers measured as the concentration of a protein in pg/mL, both types of biomarkers measured in the collected biospecimens.

  Biomarkers that distinguish between ovarian cancer and benign ovarian disease

  From enrollment through to pathology results post-surgery (usually same day)

Study Arms (2)

Pelvic Mass Cohort (cohort #1)

200 participants scheduled for surgery for suspected ovarian cancer due to a pelvic mass but without a confirmed tissue or cytology diagnosis.

Diagnostic Test: Uterine lavage, or a wash of the womb; Diagnostic Test: Blood sample; Diagnostic Test: Pap smear

BRCA1/2 Carriers Cohort (cohort #2)

50 participants with an inherited BRCA1 or BRCA2 deleterious mutation without suspected ovarian cancers who are scheduled for risk-reducing salpingo-oophorectomy (RRSO) to remove ovaries and fallopian tubes.

Diagnostic Test: Uterine lavage, or a wash of the womb; Diagnostic Test: Blood sample; Diagnostic Test: Pap smear

Interventions

Uterine lavage, or a wash of the womb DIAGNOSTIC_TEST

Uterine lavage is performed during surgery using a flexible, 3-way balloon tipped catheter. The catheter is inserted through the cervix, the balloon expanded and the uterine cavity lavaged using 10 cc of sterile saline which is collected, processed and stored for later analysis.

BRCA1/2 Carriers Cohort (cohort #2); Pelvic Mass Cohort (cohort #1)

Blood sample DIAGNOSTIC_TEST

Participants undergo two blood draws (one required, one optional) up to 31 days before surgery

BRCA1/2 Carriers Cohort (cohort #2); Pelvic Mass Cohort (cohort #1)

Pap smear DIAGNOSTIC_TEST

Participants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.

BRCA1/2 Carriers Cohort (cohort #2); Pelvic Mass Cohort (cohort #1)

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohorts will be selected from patients scheduled for ovarian disorder-related surgeries across six sites: Massachusetts General Hospital in Boston, Massachusetts; Luminis Health System in Annapolis, Maryland; Johns Hopkins University School of Medicine in Baltimore, Maryland; Kaiser Permanente - San Francisco in San Francisco, California; the Swedish Medical Center in Seattle, Washington; and the University of Arkansas for Medical Sciences in Little Rock, Arkansas.

You may qualify if:

• Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)
• Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian/fallopian tube cancer
• Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy

You may not qualify if:

• Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer
• Inability to provide informed consent
• Age less than 30 years
• Inability to obtain the minimum amount of blood
• Inability to obtain the minimum amount of uterine lavage sample
• At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm/dL)
• Prior history of known ovarian or endometrial cancer
• Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin
• History of untreated high-grade cervical dysplasia (CIN3)
• History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.
• Currently pregnant
• Known Lynch syndrome

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Johns Hopkins University: collaborator
• Fred Hutchinson Cancer Center: collaborator
• Anne Arundel Health System Research Institute: collaborator
• University of Arkansas: collaborator
• National Cancer Institute (NCI): collaborator
• Kaiser Permanente: collaborator
• McGill University: collaborator
• M.D. Anderson Cancer Center: collaborator
• Swedish Medical Center: collaborator
• Early Detection Research Network: collaborator

Study Sites (6)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Kaiser Permanente - San Francisco

San Francisco, California, 94115, United States

ACTIVE NOT RECRUITING

Anne Arundel Health System

Annapolis, Maryland, 21401, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21218, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

The Swedish Hospital

Seattle, Washington, 98122, United States

RECRUITING

Related Publications (14)

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  BACKGROUND

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  PMID: 38176019 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Serum (red-top tubes) * EDTA plasma (purple-top tubes) * Uterine Lavage supernatant (conical tube) * Uterine Lavage filter (conical tube) * Uterine Lavage cell pellet (conical tube) * Buffy coat (purple-top tubes) * Tissue sections

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Neoplasms; Ovarian Diseases

Interventions

Blood Specimen Collection; Papanicolaou Test

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques

Study Officials

• Christos Patriotis, PhD

  National Cancer Institute (NCI)

  STUDY DIRECTOR

Central Study Contacts

Jackie Dahlgren

CONTACT

206 667 3438; jdahlgre@fredhutch.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 12, 2021
• Study Start: April 13, 2020
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)