Status:
RECRUITING
Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Johns Hopkins University
Fred Hutchinson Cancer Center
Conditions:
Ovarian Neoplasms
Ovarian Epithelial Carcinoma
Eligibility:
FEMALE
30+ years
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...
Detailed Description
The study aims to elucidate the relative contributions to detection of ovarian cancer from tumor DNA in uterine lavage (UL) and protein biomarkers from blood using newly available detection and sample...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04794322
Start Date
April 13 2020
End Date
August 31 2028
Last Update
September 16 2025
Active Locations (6)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Kaiser Permanente - San Francisco
San Francisco, California, United States, 94115
3
Anne Arundel Health System
Annapolis, Maryland, United States, 21401
4
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21218