RecruitingNCT02288676

DOvEEgene/WISE Genomics: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics

Sponsor

McGill University

Enrollment

1,200 participants

Start Date

Jan 1, 2014

Study Type

OBSERVATIONAL

Conditions

Ovarian Cancer Endometrial Cancer Ovarian Neoplasms Endometrial Neoplasms Safety Screening Reduced Mortality Reduced Morbidity Early Diagnosis

Summary

This study aims to develop and validate a test for detecting ovarian and endometrial cancers early. It relies on detecting somatic mutations that are associated with these cancers from a uterine pap test. A saliva sample is also collected that acts as an internal control and has the ability to detect deleterious germline mutations associated with common hereditary cancers (such as breast, ovarian, endometrial, colon, and pancreatic cancers). A machine learning classifier is then used to discriminate between cancer and benign disease.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a genomic (genetic) test performed on cells collected during a routine gynecological procedure can detect ovarian or endometrial (uterine) cancer early — potentially before symptoms develop or before surgery reveals cancer — to improve early diagnosis outcomes for women. **You may be eligible if...** - You have a suspected or confirmed cancer of the upper genital tract (ovaries, fallopian tubes, uterus) and you are scheduled to have surgery to remove the tumor (cancer cases), OR - You are scheduled for a hysterectomy (removal of the uterus) or related surgery for a benign (non-cancerous) reason, such as fibroids or heavy bleeding (control participants) **You may NOT be eligible if...** - You are not scheduled for a surgical procedure - You are unable or unwilling to provide informed consent to participate Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Royal Victoria Hospital (Glen Site)

Montreal, Quebec, Canada

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NCT02288676

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