Cancer statistics, 2016.
Rebecca L Siegel, Kimberly D Miller, Ahmedin Jemal
https://pubmed.ncbi.nlm.nih.gov/26742998Actively Recruiting
Age: 30Years +
FEMALE
ID04794322
Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study
Led by Massachusetts General Hospital · Updated on 2025-09-16
250
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new way to detect ovarian cancer early by analyzing DNA found in a uterine wash and proteins in the blood. The study includes women who are scheduled for surgery due to suspected ovarian cancer or those with a BRCA1 or BRCA2 mutation undergoing preventive surgery. The goal is to find tests that can accurately distinguish ovarian cancer cases from benign ovarian conditions, potentially leading to earlier detection and fewer late-stage diagnoses. Participants are divided into two groups: one with about 200 women having surgery for suspected ovarian cancer and another with about 50 women with BRCA mutations undergoing risk-reducing surgery. Before surgery, blood samples are taken, and during surgery, a uterine lavage is performed to collect samples. These samples are sent to multiple labs for DNA and protein analysis, including specialized sequencing and protein assays. During the study, participants will have blood draws up to 31 days before surgery and a uterine lavage during surgery. Researchers will analyze genetic mutations and protein levels in the collected samples and compare results with surgical pathology. The primary outcome measures are genomic and protein biomarkers detected from enrollment through pathology results. Samples will also be stored for future research. The study aims to improve early ovarian cancer detection with ongoing monitoring until pathology results are available.
CONDITIONS
Brief Title
Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer
Who Can Participate
Age: 30Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Has intact uterus with no history of uterine ablation, tubal ligation, or bilateral salpingectomy
- Female aged 30 years or older
- Cohort 1: Scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian or fallopian tube cancer
- Cohort 2: Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy
You will not qualify if you...
- Current tissue or cytology diagnosis positive for ovarian or any cancer
- Unable to provide informed consent
- Younger than 30 years
- Unable to obtain required blood or uterine lavage samples
- At risk if blood is drawn (e.g., hemophilia, serious anemia with hemoglobin less than 8.0 gm/dL)
- Prior history of ovarian or endometrial cancer
- Cancer treatment within the past year for cancer that spread beyond origin (excluding hormonal therapy)
- History of untreated high-grade cervical dysplasia (CIN3)
- History of treated high-grade cervical dysplasia (CIN3) with abnormal Pap smear within past year
- Currently pregnant
- Known Lynch syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 31 days before surgery through day of surgery
Participants undergo blood draws up to 31 days before surgery and a uterine lavage during planned surgery to collect samples for ovarian cancer detection analysis.
1 to 2 visits including surgery day sample collection
Long-term Monitoring
Duration - Ongoing after surgery
Collected DNA and blood-based biospecimens are stored for future biomarker investigations to further understand ovarian cancer detection.
No additional visits required
Trial Site Locations
Total: 6 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Kaiser Permanente - San Francisco
San Francisco, California, United States, 94115
Active, Not Recruiting
3
Anne Arundel Health System
Annapolis, Maryland, United States, 21401
Actively Recruiting
4
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21218
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
The Swedish Hospital
Seattle, Washington, United States, 98122
Actively Recruiting
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Research Team
J
Jackie Dahlgren
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial.
Ian J Jacobs, Usha Menon, Andy Ryan...
https://pubmed.ncbi.nlm.nih.gov/26707054Ovarian cancer screening: development of the risk of ovarian cancer algorithm (ROCA) and ROCA screening trials.
Steven J Skates
https://pubmed.ncbi.nlm.nih.gov/22543916Early Detection of Ovarian Cancer using the Risk of Ovarian Cancer Algorithm with Frequent CA125 Testing in Women at Increased Familial Risk - Combined Results from Two Screening Trials.
Steven J Skates, Mark H Greene, Saundra S Buys...
https://pubmed.ncbi.nlm.nih.gov/28143870Evidence of Stage Shift in Women Diagnosed With Ovarian Cancer During Phase II of the United Kingdom Familial Ovarian Cancer Screening Study.
Adam N Rosenthal, Lindsay S M Fraser, Susan Philpott...
https://pubmed.ncbi.nlm.nih.gov/28240969Lavage of the Uterine Cavity for Molecular Detection of Müllerian Duct Carcinomas: A Proof-of-Concept Study.
Elisabeth Maritschnegg, Yuxuan Wang, Nina Pecha...
https://pubmed.ncbi.nlm.nih.gov/26552420Ultra-deep sequencing detects ovarian cancer cells in peritoneal fluid and reveals somatic TP53 mutations in noncancerous tissues.
Jeffrey D Krimmel, Michael W Schmitt, Maria I Harrell...
https://pubmed.ncbi.nlm.nih.gov/27152024Aging and the rise of somatic cancer-associated mutations in normal tissues.
Rosa Ana Risques, Scott R Kennedy
https://pubmed.ncbi.nlm.nih.gov/29300727Assessment of symptomatic women for early diagnosis of ovarian cancer: results from the prospective DOvE pilot project.
Lucy Gilbert, Olga Basso, John Sampalis...
https://pubmed.ncbi.nlm.nih.gov/22257524Integrated genomic analyses of ovarian carcinoma.
Cancer Genome Atlas Research Network
https://pubmed.ncbi.nlm.nih.gov/21720365