Status:
UNKNOWN
HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Roche Diagnostics GmbH
Conditions:
Endometrial Neoplasms
Postmenopause
Eligibility:
FEMALE
18+ years
Brief 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.
Detailed Description
Endometrial cancer is the most common pelvic gynecological cancer in France, ranking 5th among cancers in women in terms of incidence. The most frequent symptom is post-menopausal bleeding and is one...
Eligibility Criteria
Inclusion
- Patient with postmenopausal bleeding
- Patient requiring hysteroscopy or hysterectomy
- No objection from the patient to participate in the study
Exclusion
- 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)
Key Trial Info
Start Date :
June 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04867109
Start Date
June 25 2021
End Date
September 1 2022
Last Update
September 17 2021
Active Locations (2)
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1
Saint-Nazaire Hospital
Saint-Nazaire, Loire-Atlantique, France, 44606
2
Vendee Hospital Center
La Roche-sur-Yon, Vendee, France, 85925