DOvEEgeneIII: DOvEEgene Phase III Trial
Study Details
Study Description
Brief Summary
Early stage high-grade cancer, particularly ovarian cancer, has few, if any, symptoms. When symptoms appear, they are vague and mimic other diseases and therefore the diagnosis is missed or delayed. The McGill research group had showed in the DOvEE trial (NCT02296307), that fast-track assessment with transvaginal ultrasound scans (TVUS) and serial CA125 of women with vague symptoms associated with ovarian and endometrial cancer did diagnose these cancers earlier in the disease trajectory, with low-volume resectable disease, but only after the cancer had already become Stage III. So the only way to detect these cancers in Stage I is to screen asymptomatic women. Unfortunately, none of the currently available tests, including TVUS and CA-125 have been shown to be useful for screening for ovarian or endometrial cancer.
DOvEEgene is a genomic uterine pap test developed by a McGill team to screen and detect these cancers while they are confined to the gynecologic organs and curable by surgery. The test identifies pathogenic somatic mutations (necessary early steps in the development of these cancers), in uterine pap smears. Currently DOvEEgene is the only test that can discriminate ovarian and endometrial cancers in peri- and postmenopausal women from benign gynecologic disease common in that age group. It is able to do so by incorporating a deep machine-learning derived classifier that can discriminate the mutational signature of these cancers from benign disease with a sensitivity of 70% and a specificity of 100% in a population with high background mutational burden.
All previous testing was performed in a population of women already following standard of care treatment for malignant or benign gynecological disease. The DOvEEgene test is now ready to be tested as a phase III diagnostic test in the general population to see if these results are just as promising in the community at large.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- Early diagnosis of ovarian and endometrial cancers [3 years]
Through the identification of pathogenic somatic mutations in uterine pap sample in combination with an established machine learning algorithm, the team will discriminate cancer from benign disease in participant samples.
Secondary Outcome Measures
- Identification of germline mutations [3 years]
Detection of pathogenic germline mutations in participants' saliva sample to mitigate risks of other cancers (namely breast, ovarian, uterine and colon cancers) and diseases if participant opts for disclosure of results.
- Evaluate women's experience related to study procedures [3 years]
Assess women's experience to the genomic uterine pap sampling process using an acceptability questionnaire. It is important the participant has a good experience with the sampling and healthcare professional.
- Evaluate effects on quality of life from study participation [3 years]
We will assess effects on quality of life (QoL) to study participants, such as anxiety while awaiting results, interventions for false positives results and etc. via the SF-36 questionnaire.
- Evaluate costs of unnecessary intervention [3 years]
We will track the cost of every intervention resulting from a positive test, till we determine whether it was a false positive or not. For instances of a false positive result, we will consider the associated costs via a health economics analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Capacity to understand study and provide informed consent
Exclusion Criteria:
-
Prior hysterectomy
-
Be pregnant
-
Be nursing
-
Be undergoing any fertility treatment
-
Have had recent history of uterine perforation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McGill University Health Centre, Royal Victoria Hospital | Montreal | Quebec | Canada | H4A 3J1 |
| 2 | Queen Elizabeth Health Complex | Montréal | Quebec | Canada | H4A 3K6 |
Sponsors and Collaborators
- McGill University
- Genome Canada
- Genome Quebec
- Research Institute of the McGill University Health Center
- Molecular diagnostics lab of the MUHC (Optilab)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-6430