Degez Manon, Caillon Hélène, Chauviré-Drouard Anne, Leroy Maxime, Lair David, Winer Norbert, Thubert Thibault, Le Floch Pauline, Desroys du Roure Valérie, Randet Mélanie, Ducarme Guillaume, Dochez Vincent
Service de Gynécologie-Obstétrique, CHU de Nantes, 44000 Nantes, France.
Service de Biochimie, CHU de Nantes, 44000 Nantes, France.
Diagnostics (Basel). 2021 Jul 15;11(7):1274. doi: 10.3390/diagnostics11071274.
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.
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.
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.
子宫内膜癌是法国最常见的盆腔妇科癌症。最常见的症状是绝经后出血，也是妇科急诊就诊的主要原因之一。治疗方法非常规范，包括进行手术干预以进行解剖病理学分析。后者通常令人安心。这些干预措施通常在病情较轻的情况下进行，目前尚无足够令人安心的因素可避免手术。本研究旨在探讨一种创新标志物——人附睾蛋白4（HE4）在绝经后出血情况下子宫内膜癌诊断方法中的敏感性。
这是一项前瞻性多中心诊断研究，涉及三个中心。纳入标准为任何即将接受宫腔镜检查、子宫内膜活检或子宫内膜切除术的绝经后出血患者。根据绝经后出血的管理建议，医疗行为包括进行临床检查、超声检查，通常即使辅助检查结果令人安心，也需进行解剖病理学分析。这种病理分析可通过多种方式获得：活检、宫腔镜下刮宫（最常进行的手术）和子宫切除术。我们的方案是从将接受上述任何一种干预措施的每位女性身上采集血样。HE4和CA125的检测需要在通常进行的术前评估期间额外抽取一管肝素化血液。因此，本研究被归类为非干预性研究。主要结局是评估HE4标志物在绝经后出血患者中诊断子宫内膜癌的敏感性。次要结局是HE4的其他参数（特异性、阳性预测值、阴性预测值），评估单独使用CA125标志物以及与HE4联合使用时的诊断能力，以及REM和REM - B算法的诊断能力。我们的目标是在三个中心的一年内纳入100名患者。
截至目前，在子宫内膜癌的常规诊断中尚未使用生物标志物。HE4在子宫内膜癌中的最终目标是避免对被确定为未患病的患者进行手术。本研究是其他用于常规实践研究的先驱，如果我们的研究证明HE4在这些患者的管理中可靠且能避免许多不必要的有风险的手术，那么它将对诊断有很大帮助。
