UnknownNot Applicable

HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding

France100 participantsStarted 2021-06-25

Plain-language summary

This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient with postmenopausal bleeding * Patient requiring hysteroscopy or hysterectomy * No objection from the patient to participate in the study Exclusion Criteria: * Non-menopausal patient * Patient under guardianship, curatorship or deprived of her freedom * Patient with proven metastases on imaging * Patient with a macroscopically suspicious cervix * Patient presenting an ovarian cyst or an associated adnexal pathology * Patient contraindicated for surgical treatment (therefore not eligible for pathological analysis) * Patient who has already been treated with hormone therapy for breast cancer * Patient who has already had surgery for this pathology, with a contributing anatomopathological result (we will therefore include patients who would not benefit from an operative hysteroscopy after performing a cornier® pipelle that does not allow a positive result)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer

Timeframe: Until the pathological results (About 10-15 days)

Trial details

NCT IDNCT04867109

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-01

Contact for this trial

Vincent DOCHEZ, MD

33 2 40 08 78 00 vincent.dochez@chu-nantes.fr

View on ClinicalTrials.gov More Endometrial Neoplasms trials