Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer
研究概览
简要总结
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with postmenopausal bleeding
- •Patient requiring hysteroscopy or hysterectomy
- •No objection from the patient to participate in the study
排除标准
- •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)
结局指标
主要结局
To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer
时间窗: Until the pathological results (About 10-15 days)
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.
次要结局
- 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))
- Assess the relationship between endometrial thickness on ultrasound and HE4 and CA125 marker values(Until the pathological results (About 10-15 days))
- To evaluate the diagnostic capabilities of HE4 and CA125 in subgroups of smoking patients and patients with renal failure(Until the pathological results (About 10-15 days))
- Identify potential confounding factors associated with the value of the HE4 marker like treatments, comorbidities (renal insufficiency, high BMI) and others criteria that are collected in the medical files(Until the pathological results (About 10-15 days))