New tool for uterine sampling to detect gynecological cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop and validate a novel molecular test called DOvEEgene, which focuses on early diagnosis of endometrial, tubal, and ovarian cancers by identifying cancer-specific mutations in pap samples taken from the uterus. The study builds on previous research and seeks to improve patient tolerability during sampling by using a new uterine sampling tool. Participants will include women with suspected or confirmed gynecological diseases who are undergoing surgery for tumor removal. The study will assess the effectiveness of this new tool in detecting cancer DNA amidst a challenging background of benign conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be at least 18 years of age.
* Have capacity to understand the study.
* Be able to provide informed consent.
* If the patient has a recently treated cervical abnormality, she must have had a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy.
* Have suspected or confirmed cancer of the upper genital tract and be undergoing surgery for said tumor removal.

Exclusion Criteria:

* Prior hysterectomy.
* Be pregnant or possibly pregnant.
* Be nursing, as the device contains phthalates (plasticizers) that "have not been fully characterized and there may be concern for reproductive and developmental effects".
* Have an infected or inflamed cervix.
* Have a confirmed or suspected pelvic infection.
* Have a confirmed or suspected vaginal infection.
* Have had recent history of uterine perforation.
* Patients with recently treated cervical abnormalities must have a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy in order to be eligible.

Where it's running

• Royal Victoria Hospital (Glen Site)
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Dr. Lucy Gilbert, MD,MSc,FRCOG
• Email: lucy.gilbert@mcgill.ca
• Phone: (514) 934-1934

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.