Early Detection of Endometrial/Ovarian Cancer & Hereditary Predisposition

Status Recruiting

Clinical Trial Summary

Early stage high-grade cancer, endometrial and ovarian, has few, if any, symptoms or signs. When symptoms appear, the disease may be in advanced stage as the disease has left the gynaecological organs and metastasized to the pelvic/abdominal cavity. 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. One way to detect these cancers earlier 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. 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 identifies pathogenic somatic mutations (necessary early steps in the development of these cancers), in an uterine cytological sample. 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. In addition to the intra-uterine cytological sample, the test includes an assay of a saliva sample to identify germline mutations that predispose to hereditary endometrial/ovarian cancers as well as breast and colon cancers. The test was developed in a retrospective population in whom the assay was done pre-operatively and the diagnosis of malignancy versus benign gynecological disease was confirmed by detailed pathological analysis of the uterus, tubes, and ovaries after surgical resection (NCT02288676). The 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04891029
Study type	Interventional
Source	McGill University
Contact	Lucy Gilbert, MD
Phone	514-934-1934
Email	gyne-oncologysec@mcgill.ca
Status	Recruiting
Phase	N/A
Start date	May 10, 2021
Completion date	April 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Early Detection of Endometrial/Ovarian Cancer and Hereditary Predisposition of These Cancers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms