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

NCT04867109 | Unknown

• 1 other identifier: RC21_0166
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Endometrial cancer; Human epididymis protein 4; HE4; CA125; Post-menopausal bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  Until the pathological results (About 10-15 days)

Secondary Outcomes (8)

• Assess other diagnostic parameters (specificity, PPV, NPV) of HE4

  Until the pathological results (About 10-15 days)

• 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)

• 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)

• 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)

• Reassess the pathological threshold value of endometrial thickness on ultrasound

  Until the pathological results (About 10-15 days)

Interventions

Patients with Post menopausal bleeding OTHER

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.

CA125 and HE4 assays DIAGNOSTIC_TEST

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).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adults women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient with postmenopausal bleeding
• Patient requiring hysteroscopy or hysterectomy
• No objection from the patient to participate in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (2)

Saint-Nazaire Hospital

Saint-Nazaire, Loire-Atlantique, 44606, France

RECRUITING

Vendee Hospital Center

La Roche-sur-Yon, Vendee, 85925, France

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vincent DOCHEZ, MD

CONTACT

33 2 40 08 78 00; vincent.dochez@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 30, 2021
• Study Start: June 25, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)