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

NCT04867109UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Nantes University Hospital

Enrollment

100

Start Date

2021-06-25

Completion Date

2022-08-01

Study Type

OBSERVATIONAL

Official Title

Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding

Interventions

Patients with Post menopausal bleedingCA125 and HE4 assays

Conditions

Endometrial NeoplasmsPostmenopauseUterine HemorrhageCancer BiomarkerCA 125 Antigen

Eligibility

Age Range

18 Years+

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

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

The HE4 assays will be performed using the electrochemiluminescence (ECL) technique on Cobas Pro module E801, Roche Diagnostics. The HE4 assay is based on a sandwich-type electrochemiluminescence method. The HE4 assay with the Roche Diagnostics Elecsys reagent has been standardized against the Fujirebo Diagnostics HE4 EIA method. Positive/negative HE4 result for the estimation of the sensitivity of HE4 in the diagnosis of endometrial cancer. The commonly accepted threshold for ovarian cancer management of 140pmol/l in postmenopausal patients should be used. The gold standard for endometrial cancer is the pathological result (absence/presence of cancer) of the sample taken.