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

NCT02288676RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

McGill University

Enrollment

1200

Start Date

2014-01-01

Completion Date

2025-10-01

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsEndometrial CancerOvarian CancerScreeningSafetyReduced MortalityReduced MorbidityEarly Diagnosis

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Detection of cancer-related mutations

Diagnosis ovarian and endometrial cancers by detection of cancer-related mutation taken by brush sample of uterus with high sensitivity and specificity.

Time frame: 3 years

Secondary Outcomes

Patient related outcomes including pain and acceptability

Pain scores reported by participants on numeric pain and discomfort scale (NPS). Patients' attitude towards the test including willingness to have it done on an annual basis will be evaluated.

Time frame: 3 years

Risks associated with the DOvEEgene test

Evaluate all risks associated with the DOvEEgene test including complications from the sampling technique as well as unnecessarily interventions resulting from false positive tests.

Time frame: 3 years

Locations

Royal Victoria Hospital (Glen Site), Montreal, Canada