DOvEEgene Phase III Trial (DOvEEgeneIII)

  • STATUS
    Recruiting
  • End date
    Apr 19, 2026
  • participants needed
    3600
  • sponsor
    McGill University
Updated on 4 October 2022
Accepts healthy volunteers

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.

Details
Condition Diagnoses Disease
Treatment DOvEEgene test
Clinical Study IdentifierNCT04891029
SponsorMcGill University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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