Recruiting

Genomics

Sponsor:

McGill University

Code:

NCT02288676

Conditions

Ovarian Neoplasms

Endometrial Neoplasms

Endometrial Cancer

Ovarian Cancer

Screening

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Ovarian Neoplasms

Endometrial Neoplasms

Endometrial Cancer

Ovarian Cancer

Screening

Study ID

NCT02288676

Start date

Jan, 2014

Status verified date

Jun, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Case Inclusion:

  • Subjects should have suspected or confirmed cancer of the upper genital tract.
  • Participant will undergo surgery for tumour removal.

Control inclusion:

• Subjects should be scheduled to have a hysterectomy, bilateral salpingectomy, with or without bilateral oophorectomy, for presumed benign disease.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Case Group

Participants must have suspected or confirmed upper genital tract cancer (uterine, tubal and ovarian) and must be scheduled to undergo surgery for tumor removal.

Control Group

Participants must not be under investigation for any pre-cancerous or cancerous lesions of the genital tract, and must be scheduled for a hysterectomy, bilateral salpingectomy with/without bilateral oopherectomy for presumed benign condition.

Primary outcome measure

  • Detection of cancer-related mutations [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Dr. Lucy Gilbert, MD,MSc,FRCOG

(514) 934-1934lucy.gilbert@mcgill.ca

Locations

Royal Victoria Hospital (Glen Site)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Dr. Lucy Gilbert, MD,MSc,FRCOG

(514)934-1934lucy.gilbert@mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Jun 18, 2025

Last verified

Jun, 2025

Keywords

  • genomics
  • somatic mutations
  • genetic mutations
  • high-grade serous cancer
  • ovarian cancer
  • endometrial cancer
  • DNA tagging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2025-06-18.