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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    100
  • sponsor
    Nantes University Hospital
Updated on 27 September 2021
cancer
hysterectomy
ca-125

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.

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.

Details
Condition Menopause, ca 125, Disorder of uterus NOS, Postmenopause, Endometrial Cancer, Cancer Biomarker, Vaginal Bleeding, Uterine Cancer, Endometrial Carcinoma, ca-125, cancer antigen 125, CA-125 Antigen, uterine bleeding, Uterine Disorders, Post Menopause, Hemorrhage
Treatment Patients with Post menopausal bleeding, CA125 and HE4 assays
Clinical Study IdentifierNCT04867109
SponsorNantes University Hospital
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

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)
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