Clinical trial · Observational
HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
NCT04867109CI-TRIAL-00053943METRODECunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CA 125 Antigen | — | UNRESOLVED | — |
| Cancer Biomarker | — | UNRESOLVED | — |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Postmenopause | — | UNRESOLVED | — |
| Uterine Hemorrhage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CA125 and HE4 assays | Diagnostic Test | — | UNRESOLVED |
| Patients with Post menopausal bleeding | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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)
- description
- 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 outcomes (8)
- measure
- Assess other diagnostic parameters (specificity, PPV, NPV) of HE4
- timeFrame
- Until the pathological results (About 10-15 days)
- description
- ROC curve for the HE4 marker in the diagnosis of endometrial cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.