HE4 in the Diagnostic Approach of Endometrial Cancer in Patients with Postmenopausal Bleeding, the METRODEC Protocol: Protocol for a Multicenter Prospective Study

Diagnostics

Anne Chauviré-Drouard¹  David Lair²  Maxime Leroy³  Hélène Caillon⁴  Guillaume Ducarme⁵  Mélanie Randet⁶  Thibault Thubert⁷  Norbert Winer⁷  Vincent Dochez⁷  Manon Degez⁷  Valérie Desroys du Roure⁸  Pauline Le Floch⁹ 

[1] Centre d’Investigation Clinique CIC 1413, INSERM, CHU de Nantes, 44000 Nantes, France;Département Promotion, Direction de la Recherche, CHU de Nantes, 44000 Nantes, France;Plateforme de Biométries et Biostatistiques, CHU de Nantes, 44000 Nantes, France;Service de Biochimie, CHU de Nantes, 44000 Nantes, France;Service de Gynécologie-Obstétrique, CH Départemental Vendée, 85000 La Roche sur Yon, France;Service de Gynécologie-Obstétrique, CH de Saint-Nazaire, 44600 Saint-Nazaire, France;Service de Gynécologie-Obstétrique, CHU de Nantes, 44000 Nantes, France;Unité de Recherche Clinique, CH Départemental Vendée, 85000 La Roche sur Yon, France;Unité de Recherche Clinique, CH de Saint-Nazaire, 44600 Saint-Nazaire, France;

关键词: endometrial cancer;    human epididymis protein 4;    HE4;    CA125;    postmenopausal bleeding;    hysteroscopy;   

DOI  :  10.3390/diagnostics11071274

来源: DOAJ

【 摘 要 】

Background: Endometrial cancer is the most common pelvic gynecological cancer in France. The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies. The treatment is very codified and consists of a surgical intervention for anatomopathological analysis. The latter is frequently reassuring. These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery. This study aims to explore the sensitivity of an innovative marker: Human Epididymis 4 (HE4) in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings. Methods: This is a prospective multicenter diagnostic study with three centers involved. Inclusion criteria are any patient with post-menopausal bleeding who is to undergo hysteroscopy, endometrial biopsy, or endometrial resection. In accordance with the recommendations for the management of post-menopausal bleedings, the medical conduct consists of performing a clinical examination, an ultrasound and, in general, even in case of paraclinical examination reassuring, an anatomopathological analysis. This pathological analysis can be obtained in several ways: biopsy, hysteroscopy-curettage (which is the most frequently performed surgery), and hysterectomy. Our protocol consists of taking a blood sample from each woman who will undergo one of the interventions mentioned above. The dosage of HE4 and CA125 requires the withdrawal of an additional heparinized tube during the preoperative assessment usually performed. This research is therefore classified as non-interventional. The primary outcome is to evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer. The secondary outcomes are other parameters (specificity, VPP, VPN) of HE4, Evaluating the diagnostic capabilities of the CA125 marker alone and associated with HE4, as well as those of the REM and REM-B algorithms. We aim to include 100 patients over a period of one year in three centers. Discussion: As of now, there is no biological marker used in routine practice in the diagnosis of endometrial cancer. The ultimate goal of HE4 in endometrial cancer is to avoid surgery for those who are identified as non-sick. This study is the precursor of others for use in routine practice, HE4 would represent a great help to diagnosis if our study demonstrates it as reliable in the management of these patients and avoid many unnecessary and risky surgeries.

【 授权许可】

Unknown