Screening Test for Detecting Ovarian and Endometrial Cancer

(FemGene Trial)

Recruiting at 2 trial locations

Overseen By Lucy Gilbert, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Hysterectomy, Pregnant, Nursing, Fertility treatment, others

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

Compensation: Varies

Number of Visits: Unknown

5600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new screening test, DOvEEgene, for early detection of ovarian and endometrial cancers. The test analyzes a uterine sample to identify early signs of these cancers before symptoms appear. It also includes a saliva sample to assess inherited risks for other cancers. Women who are peri- or post-menopausal and have not had a hysterectomy might be suitable candidates for this trial. The goal is to detect these cancers earlier, leading to better treatment outcomes. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to earlier cancer detection and improved survival rates.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this genomic assay is safe for screening ovarian and endometrial cancer?

Research has shown that the DOvEEgene test is safe for individuals. Designed to detect ovarian and endometrial cancers early, it analyzes a sample from the uterus and a saliva sample for specific DNA changes linked to cancer.

In previous studies, the DOvEEgene test effectively identified cancer early, correctly detecting it 80% of the time. It also achieved a 100% accuracy rate in avoiding false positives in healthy women undergoing or having completed menopause. This indicates the test can accurately detect cancer while preventing unnecessary concern in these women.

The test was also evaluated in a group of individuals before surgery. The results aligned well with detailed examinations conducted after the removal of their uterus and ovaries, suggesting the test's reliability. No reports of safety issues or side effects have emerged from using the DOvEEgene test. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DOvEEgene test because it offers a new way to detect ovarian and endometrial cancers early on, which is crucial for improving outcomes. Unlike current methods that often rely on symptoms or invasive procedures, DOvEEgene uses a non-invasive genetic screening technique to identify cancer markers before symptoms appear. This approach could lead to earlier diagnosis and treatment, potentially increasing survival rates and reducing the need for more aggressive interventions later.

What evidence suggests that the DOvEEgene test is effective for detecting ovarian and endometrial cancer?

Research has shown that the DOvEEgene test can detect ovarian and endometrial cancers earlier than current methods. It can identify cancer at stage 1, whereas traditional tests often detect it at stages 3 or 4. The test works by spotting genetic changes that indicate early cancer development. In past studies, it correctly identified 80% of actual cancer cases, demonstrating 80% sensitivity. It also achieved 100% specificity, accurately identifying healthy individuals without cancer. These results suggest the DOvEEgene test could be a promising tool for early detection of these cancers. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

The DOvEEgene Phase III Trial is for peri- and postmenopausal women who can understand the study and consent to participate. Women who've had a hysterectomy, are pregnant or nursing, undergoing fertility treatments, or have a recent history of uterine perforation cannot join.

Inclusion Criteria

I understand the study and can give my consent.

I understand the study and can give my consent.

Exclusion Criteria

I have had a hysterectomy.

I have had a recent uterine perforation.

Be undergoing any fertility treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo genomic assay testing using uterine cytological and saliva samples to detect somatic and germline mutations.

3 years

Multiple visits for sample collection and follow-up

Follow-up

Participants are monitored for safety, effectiveness, and quality of life impacts after diagnostic testing.

3 years

Regular follow-up visits and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• DOvEEgene

Trial Overview This trial tests the DOvEEgene test, a genomic uterine pap smear designed to detect early-stage ovarian and endometrial cancers in asymptomatic women by identifying specific cancer-related mutations with high accuracy.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Genome Canada

Collaborator

Trials

17

Recruited

34,400+

Genome Quebec

Collaborator

Trials

8

Recruited

19,800+

Research Institute of the McGill University Health Center

Collaborator

Trials

3

Recruited

5,000+

Molecular diagnostics lab of the MUHC (Optilab)

Collaborator

Trials

1

Recruited

3,600+

Published Research Related to This Trial

The Screenwide study enrolled over 800 women, including those with endometrial and ovarian cancers, BRCA1/2 and MMR pathogenic variant carriers, to evaluate new early detection strategies for gynecological cancers.

Preliminary results indicate that genetic variants in tumors can be effectively detected in minimally invasive samples, with high detection rates of 90% in endometrial aspirates, suggesting a promising approach for early cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Approach for the Early Detection of Endometrial and Ovarian Cancers (Screenwide Study): Rationale, Study Design and Pilot Study. Peremiquel-Trillas, P., Paytubi, S., Pelegrina, B., et al.[2023]

Ovarian cancer is a leading cause of death among gynecological cancers, with 60% to 70% of patients diagnosed at an advanced stage, highlighting the urgent need for early detection methods.

Current screening methods, including pelvic exams, cytology, and imaging, have limitations, but advancements in tumor immunology may offer the best hope for developing effective screening tests for early diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early diagnosis of ovarian cancer. Popkin, DR.[2018]

In a study of 545 women with a positive family history of ovarian cancer, only two cases of ovarian cancer were detected during 2266 years of follow-up, indicating that annual screening may not be effective in identifying early-stage ovarian cancer in this population.

The study revealed a high recall rate for further testing, particularly in the high-risk group (14%), suggesting that while screening is conducted, it may lead to unnecessary anxiety and additional procedures without significantly improving early detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for ovarian cancer in women with varying levels of risk, using annual tests, results in high recall for repeat screening tests. Nobbenhuis, MA., Bancroft, E., Moskovic, E., et al.[2021]

A novel screening strategy using CA125 levels every three months, combined with a risk of ovarian cancer algorithm (ROCA), showed improved early-stage detection of ovarian cancer in women at high genetic risk, with 50% of incident cases detected at early stages compared to only 10% in historical controls.

The screening method demonstrated high specificity (92%) for ultrasound referrals, and while the positive predictive value (PPV) was lower (4.6% compared to 10% in general population screening), it still indicated a potentially acceptable level of effectiveness for early detection, suggesting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early 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. Skates, SJ., Greene, MH., Buys, SS., et al.[2022]

Ovarian cancer has a high mortality rate, with only a 31% five-year survival rate for advanced stages, highlighting the critical need for early diagnosis, which is currently challenging due to the lack of specific symptoms and effective screening methods.

Current screening tests, such as CA-125 and transvaginal ultrasound, do not have the necessary sensitivity and specificity for the general population, and even high-risk women have not shown benefits from screening in prospective studies, indicating a significant public health challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening: a look at the evidence. Fields, MM., Chevlen, E.[2015]

The study analyzed data from 92,843 health plan members and found that using the multivariate assay OVA1 instead of the CA125 test for assessing pelvic masses could lead to modest cost savings of $0.05 per-member per-month for commercially insured patients and $0.01 for Medicare beneficiaries.

Switching to OVA1 not only offers potential economic benefits but also improves diagnostic accuracy for ovarian cancer, allowing for earlier detection and reducing unnecessary referrals to specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Impact of Increased Utilization of Multivariate Assay Testing to Guide the Treatment of Ovarian Cancer: Implications for Payers. Brodsky, BS., Owens, GM., Scotti, DJ., et al.[2022]

Annual screening for ovarian cancer in women with a family history did not significantly reduce overall or disease-specific mortality compared to usual care, based on a study of 78,216 women.

However, women in the screening group were diagnosed at earlier stages of ovarian cancer and had significantly improved survival rates, suggesting that while screening may not lower mortality, it could lead to better outcomes for those diagnosed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening in menopausal females with a family history of breast or ovarian cancer. Lai, T., Kessel, B., Ahn, HJ., et al.[2018]

Early detection of ovarian cancer is crucial, as over 90% of Stage I cases can be cured, yet currently, less than 25% are diagnosed at this early stage.

While CA-125 is a key serum marker for screening, its isolated values are not sensitive enough; however, monitoring CA-125 levels over time can improve specificity to 99.6%, though sensitivity remains a challenge, indicating the need for more advanced screening strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of tumor markers in ovarian cancer screening. Bast, RC.[2016]

Screening for ovarian cancer using CA125 and ultrasound in asymptomatic, general-risk postmenopausal women has low positive predictive values, leading to a high rate of false positives and unnecessary surgeries.

The review of 20 studies indicates that there is insufficient evidence to recommend routine ovarian cancer screening in this population, as it does not significantly improve early detection rates and is associated with increased patient anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening postmenopausal women for ovarian cancer: a systematic review. Fung, MF., Bryson, P., Johnston, M., et al.[2022]

Ovarian cancer is a leading cause of death among women, with survival rates significantly higher for early-stage diagnosis (95% survival at stage I) compared to advanced stages (15-30% survival).

The OvaCheck test, which utilizes proteomic technology, is expected to provide a highly specific and sensitive method for early detection of ovarian cancer in women at high risk, although it is still awaiting FDA approval for nationwide use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and detection of ovarian cancer. Breedlove, G., Busenhart, C.[2015]

The PapSEEK test can effectively detect endometrial cancers with an 81% success rate and ovarian cancers with a 33% success rate by analyzing DNA for specific mutations and chromosome number changes.

This test has a low false-positive rate, making it a promising tool for early cancer detection in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening Tool for Gynecologic Cancers Assessed. [2019]

Ovarian cancer is a significant health concern, being the second most common reproductive system cancer and the leading cause of gynecologic cancer deaths in the U.S., with a low overall 5-year survival rate.

Screening methods such as pelvic examinations, sonography, and serum CA-125 levels are crucial for early diagnosis, with sonography and CA-125 showing the most promise based on extensive studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology and screening of ovarian cancer. Tortolero-Luna, G., Mitchell, MF., Rhodes-Morris, HE.[2005]

The new ovarian cancer screening strategy using the ROC algorithm demonstrated high specificity (99.8%) and a positive predictive value (PPV) of 19% for detecting primary invasive epithelial ovarian cancer in a study of 13,582 postmenopausal women.

This screening approach is feasible and is currently being implemented in major clinical trials in the UK and the US, indicating its potential for broader application in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study using the risk of ovarian cancer algorithm to screen for ovarian cancer. Menon, U., Skates, SJ., Lewis, S., et al.[2016]

Screening for ovarian cancer using CA 125 and transvaginal sonography was found to increase average life expectancy by less than 1 day for a cohort of 40-year-old women in the U.S.

The minimal impact on life expectancy suggests that mass screening for ovarian cancer with these methods may not be an effective health policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of ovarian cancer screening. A decision analysis model. Schapira, MM., Matchar, DB., Young, MJ.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02288676

DOvEEgene/WISE Genomics: Diagnosing Ovarian and ... This study aims to develop and validate a test for detecting ovarian and endometrial cancers early. It relies on detecting somatic mutations that are ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7617385/

Screening and prevention of ovarian cancer - PMC Our review summarises and appraises the spectrum of ovarian cancer screening and targeted preventive approaches for reducing ovarian cancer risk.

3. doveegene.com doveegene.com/

DOvEEgene: Home The DOvEEgene test finds cancer as early as stage 1 versus stage 3 or 4 with current methods. Participate in our trials.

4. ctv.veeva.com ctv.veeva.com/study/doveegene-phase-iii-trial

Early Detection of Endometrial/Ovarian Cancer and Hereditary ... The McGill team has developed a genomic assay to screen and detect these cancers earlier in the trajectory than is currently the case. The test ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04258449

DOvEEgene Fleur: New Uterine Sampling Tool This study is designed to identify endometrial, tubal and ovarian cancer very early based on identifying cancer-specific mutations (cancer DNA) in a pap sample ...

6. aacrjournals.org aacrjournals.org/cancerres/article/83/7_Supplement/6522/722946/Abstract-6522-Improved-detection-of-low-frequency

Improved detection of low frequency mutations in ovarian and ... Currently, DOvEEgene is the only test that can discriminate ovarian and endometrial cancers in peri- and postmenopausal women from benign ...