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

NCT ID: NCT04867109

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-25
• Study Completion Date: 2022-09-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Patients with Post menopausal bleeding

Any patient presenting post-menopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the determination of the serum markers HE4 and CA125, after having obtained her non-opposition to participate in the study.

The blood tube collected for the research will be sent to the biochemistry laboratory of the Nantes University Hospital for a centralized analysis.

This analysis will be done sequentially and the results will not be transmitted to the investigator.

At D0, the day of surgery, the operative report will be retrieved as well as the quality of life questionnaires SF12 and PGI-I and the acceptability questionnaire completed before surgery.

At 1 month after surgery, the anatomopathological results will be retrieved as well as the value of the tumour markers CA125 and HE4.

Intervention Type: OTHER

CA125 and HE4 assays

Blood was collected in a standard heparinized vial. Samples were sent to a central laboratory unit (biochemistry laboratory at the Nantes university hospital), centrifuged and plasmas were stored at -20°C until analysis. Plasma CA125 and HE4 concentrations were determined by run in single measurements using an electrochemiluminescence Elecsys immunoassay (ECLIA) on a Roche Diagnostics Cobas 8000® e602 analyser (Roche Diagnostics, Mannheim, Germany).

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint-Nazaire Hospital

Saint-Nazaire, Loire-Atlantique, France

Site Status: RECRUITING

Vendee Hospital Center

La Roche-sur-Yon, Vendee, France

Site Status: RECRUITING

Countries

France

Central Contacts

Vincent DOCHEZ, MD

Role: CONTACT

vincent.dochez@chu-nantes.fr

33 2 40 08 78 00

Other Identifiers

RC21_0166

Identifier Type: -

Identifier Source: org_study_id