DOvEEgene Fleur: New Uterine Sampling Tool

Launched by MCGILL UNIVERSITY · Feb 5, 2020

Keywords

ClinConnect Summary

The DOvEEgene Fleur clinical trial is studying a new tool designed to collect samples from the uterus to help detect certain types of gynecological cancers, like endometrial, tubal, and ovarian cancer. This new tool aims to make the sampling process more comfortable for patients while being effective at identifying cancer by looking for specific DNA changes in the cells. This trial is a follow-up to earlier research that focused on creating a test for early cancer diagnosis and hopes to improve the experience of women undergoing this procedure.

To participate in the trial, women must be at least 18 years old and have suspected or confirmed cancer of the upper genital tract. They should also be scheduled for surgery to remove the tumor. Some women may not be eligible if they have had a hysterectomy, are pregnant or nursing, or have certain infections. Participants will experience the new sampling tool, which is designed to be less painful than previous methods, and they will play an important role in helping researchers determine if this tool can improve cancer detection and patient comfort.

Gender

FEMALE

Eligibility criteria

• 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.