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

Nantes University Hospital (NUH)

Status: Unknown

Conditions: Uterine Hemorrhage; Postmenopause; Endometrial Neoplasms; CA 125 Antigen; Cancer Biomarker

Treatments: Diagnostic Test: CA125 and HE4 assays; Other: Patients with Post menopausal bleeding

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04867109

RC21_0166

Details and patient eligibility

About

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

Full 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 of the primary reasons for consultation in gynecological emergencies.

The diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention. The latter is mostly reassuring.

These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery.

At present, there is no biological marker used in current practice. In the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis, the pathology results are often reassuring. These procedures could have been avoided, especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky. The appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)