Clinical trial NCT04867109: HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
Official title: Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Neoplasms
Postmenopause
Uterine Hemorrhage
Cancer Biomarker
CA 125 Antigen
Keywords: Endometrial cancer
Human epididymis protein 4
HE4
CA125
Post-menopausal bleeding
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2021-04-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with postmenopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the measurement of the serum markers HE4 and CA125 after she has indicated that she does not wish to participate in the study

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer
timeFrame: Until the pathological results (About 10-15 days)
Secondary outcomes:
measure: Assess other diagnostic parameters (specificity, PPV, NPV) of HE4
timeFrame: Until the pathological results (About 10-15 days)
measure: Establish the optimal threshold of HE4 for the diagnosis of endometrial cancer (use of an ROC curve)
timeFrame: Until the pathological results (About 10-15 days)
measure: 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
timeFrame: Until the pathological results (About 10-15 days)
measure: Establish the existence of thresholds for HE4 and/or CA125 markers predictive of disease severity (FIGO stage)
timeFrame: Until the results of the extension assessment in the event of proven endometrial cancer (1 month)
measure: Reassess the pathological threshold value of endometrial thickness on ultrasound
timeFrame: Until the pathological results (About 10-15 days)
measure: Assess the relationship between endometrial thickness on ultrasound and HE4 and CA125 marker values
timeFrame: Until the pathological results (About 10-15 days)
measure: To evaluate the diagnostic capabilities of HE4 and CA125 in subgroups of smoking patients and patients with renal failure
timeFrame: Until the pathological results (About 10-15 days)
measure: 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
timeFrame: Until the pathological results (About 10-15 days)
Other outcomes:
Locations:
city: Saint-Nazaire
country: France
facility: Saint-Nazaire Hospital
state: Loire-Atlantique
city: La Roche-sur-Yon
country: France
facility: Vendee Hospital Center
state: Vendee
Study officials:
References: