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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04867109

Collaborator

Roche Diagnostics (Industry)

100

Enrollment

Locations

14.2

Anticipated Duration (Months)

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Neoplasms Postmenopause Uterine Hemorrhage Cancer Biomarker CA 125 Antigen	Other: Patients with Post menopausal bleeding Diagnostic Test: CA125 and HE4 assays

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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 25, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer [Until the pathological results (About 10-15 days)]
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.

Secondary Outcome Measures

Assess other diagnostic parameters (specificity, PPV, NPV) of HE4 [Until the pathological results (About 10-15 days)]
ROC curve for the HE4 marker in the diagnosis of endometrial cancer.
Establish the optimal threshold of HE4 for the diagnosis of endometrial cancer (use of an ROC curve) [Until the pathological results (About 10-15 days)]
Search for the threshold with the best specificity of HE4 in the diagnosis of endometrial cancer
Evaluate the diagnostic capabilities of CA125 alone and in combination with HE4, as well as the REM and REM-B algorithms for the diagnosis of endometrial cancer [Until the pathological results (About 10-15 days)]
Estimation of sensitivity, specificity, PPV and NPV in the diagnosis of endometrial cancer for the CA125 biomarker and the REM and REM B algorithms
Establish the existence of thresholds for HE4 and/or CA125 markers predictive of disease severity (FIGO stage) [Until the results of the extension assessment in the event of proven endometrial cancer (1 month)]
Search for HE4 and CA125 marker thresholds to assess disease severity by FIGO stage
Reassess the pathological threshold value of endometrial thickness on ultrasound [Until the pathological results (About 10-15 days)]
Search for the pathological threshold of endometrial thickness in the diagnosis of endometrial cancer
Assess the relationship between endometrial thickness on ultrasound and HE4 and CA125 marker values [Until the pathological results (About 10-15 days)]
Estimation of the relationship between CA125 and HE4 markers and endometrial thickness on ultrasound
To evaluate the diagnostic capabilities of HE4 and CA125 in subgroups of smoking patients and patients with renal failure [Until the pathological results (About 10-15 days)]
Estimation of sensitivity, specificity, PPV and NPV in the diagnosis of endometrial cancer for HE4 and CA125 in patients with active smoking and/or renal failure
Identify potential confounding factors associated with the value of the HE4 marker like treatments, comorbidities (renal insufficiency, high BMI) and others criteria that are collected in the medical files [Until the pathological results (About 10-15 days)]
Analyses of variables measured at inclusion that may influence the value of the HE4 marker.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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)