Uterine Lavage Test for Ovarian Cancer

Recruiting at 6 trial locations

Overseen By Jackie Dahlgren

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Ovarian cancer, Endometrial cancer, Cervical dysplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for early ovarian cancer detection using a uterine lavage and a blood sample. Researchers aim to identify DNA and proteins that indicate ovarian cancer before surgery. If successful, these tests could enable early detection, potentially saving lives. Women with a pelvic mass scheduled for surgery or those with a BRCA1 or BRCA2 mutation planning ovary removal may be suitable for this trial. As an unphased study, this trial allows participants to contribute to groundbreaking research that could lead to earlier ovarian cancer detection.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these tests are safe?

Research has shown that uterine lavage, a gentle wash of the womb, is generally safe. Studies did not report any serious issues. Some participants experienced minor bleeding, but it was not severe. In studies with female horses, mild inflammation occurred, but it did not harm the womb or affect pregnancy.

Pap smears are widely considered safe for checking cervical cancer. They might cause some discomfort, but serious problems are rare.

Taking blood samples is routine and generally safe. Proper handling is necessary because blood samples can carry infections, but this is standard for any blood sample. When proper procedures are followed, the risk remains low.

Overall, these methods are well-tolerated and have a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance early detection of ovarian cancer through a novel approach. Unlike traditional methods like imaging and blood tests that often catch the disease at a later stage, this trial explores uterine lavage as a potential game-changer. By collecting cells directly from the uterus and examining them for cancer markers, researchers hope to pinpoint ovarian cancer earlier and more accurately. This could lead to earlier interventions and improved outcomes for patients at risk.

What evidence suggests that this trial's tests could be effective for early detection of ovarian cancer?

This trial will evaluate different methods for detecting ovarian cancer. Studies have shown that washing the uterus, known as uterine lavage, can help detect cancer mutations. In one study, cancer DNA appeared in the uterine wash of more than two-thirds of women with ovarian cancer, indicating its potential for early detection. Participants in the Pelvic Mass Cohort (cohort #1) will undergo uterine lavage as part of the study. While Pap smears are not useful for detecting ovarian cancer, uterine lavage shows promise because it can collect and identify cancer cells from the ovaries. Additionally, blood tests can help identify women at high risk due to BRCA1 or BRCA2 gene mutations, which will be a focus for participants in the BRCA1/2 Carriers Cohort (cohort #2). Overall, using these methods together might help catch ovarian cancer earlier than before, which is important for effective treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Christos Patriotis, PhD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Sample Collection

Participants undergo blood draws and uterine lavage sample collection before surgery

Up to 31 days

1 visit (in-person)

Surgery and Sample Analysis

Participants undergo planned surgery, and collected samples are analyzed for tumor DNA and protein biomarkers

Same day as surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery and sample analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood sample
• Pap smear
• Uterine lavage

How Is the Trial Designed?

Group I: Pelvic Mass Cohort (cohort #1) Experimental Treatment 3 Interventions

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

Group II: BRCA1/2 Carriers Cohort (cohort #2) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Early Detection Research Network

Collaborator

Trials

4

Recruited

17,500+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

Swedish Medical Center

Collaborator

Trials

55

Recruited

8,500+

Anne Arundel Health System Research Institute

Collaborator

Trials

8

Recruited

760+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

TwinStrand Biosciences

Collaborator

Trials

1

Recruited

250+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4169670/

The Role of Testing for BRCA1 and BRCA2 Mutations in ... The increase in ovarian cancer risk is even greater–from a 1.4% lifetime risk without the mutations to over 40% among BRCA1 carriers and nearly 20% among BRCA2 ...

2. cancer.gov cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet

BRCA Gene Changes: Cancer Risk and Genetic Testing The risks of developing breast and ovarian cancer are markedly increased in people who inherit a harmful change in BRCA1 or BRCA2.

3. sciencedirect.com sciencedirect.com/science/article/pii/S009082582101516X

Probability of detecting germline BRCA1/2 pathogenic ... The probability of detecting a germline BRCA1/2 PV varied widely among the various histological subtypes of OC; ranging from 22.2% (95% CI 19.6 to 25.0) in ...

4. nature.com nature.com/articles/s41467-023-38925-4

Identification of BRCA1/2 mutation female carriers using ... Circulating microRNAs may be used to identify BRCA1/2 mutations in patients of high risk of cancer, offering an opportunity to reduce screening costs.

5. clinicalepigeneticsjournal.biomedcentral.com clinicalepigeneticsjournal.biomedcentral.com/articles/10.1186/s13148-024-01787-8

BRCA1 & BRCA2 methylation as a prognostic and predictive ... Although BRCA2 mutations have been found only in 1–3% of cases, BRCA2 mutation carriers are two-fold to four-fold more likely to develop an ...

6. biomol.com biomol.com/msds/RD_BLD_MSDS_for_Human_Whole_Blood.pdf

Safety Data Sheet for Human Whole Blood Human whole blood is harmful if swallowed, in contact with skin or inhaled. Wear gloves/eye protection. Store at 2-8°C. Handle as potentially ...

7. edvotek.com edvotek.com/site/pdf/Simulated%20Blood%20Sample.pdf?srsltid=AfmBOopK3DG9qdh96FNOtMXqGEEC0SiJ6bGYXu5oBwFZd0pAOJloI51F

SDS – Simulated Blood Sample The simulated blood sample may be harmful if inhaled, absorbed through skin, or swallowed. It may cause skin and eye irritation. No special measures are ...

8. utak.com utak.com/wp-content/uploads/2022/08/Whole-Blood-Toxicology-Control-SDS.pdf

Safety Data Sheet Whole Blood/Toxicology Control - Utak The product is whole blood, with no hazardous ingredients, but should be treated as a potential infectious agent. No GHS categories are applicable.

9. sigmaaldrich.com sigmaaldrich.com/sds/sigma/h4522?srsltid=AfmBOorcP7waIcWIoN52OPiHWt-_INWkDaf8CDf6-N5kXfeGyFfzSiKd

SAFETY DATA SHEET The product is not hazardous, but is human source material. For skin contact, rinse with water. For eye contact, rinse with water and remove ...

10. nhsbtdbe.blob.core.windows.net nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/30947/inf130-260kb.pdf

INF130/2 – Safety Data sheet NHSBT Whole Blood Controls No known test methods can offer assurances that products derived from human blood will not transmit infectious diseases. This device should be ...