Estimated Levels of Plasma MicroRNA 125b-5p and 141-3p Enforce the Diagnostic Accuracy for Early Endometriosis: A Comparative Study Versus Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Diagnostic Sensitivity and Specificity of Plasma MicroRNA 125b-5p Fold Change for Differentiating Early Endometriosis
研究概览
简要总结
Endometriosis (EM) is a chronic gynecological disorder characterized by distressing pain and a high risk of infertility. While exploratory laparoscopy is currently the standard for diagnosis and staging, it is an invasive surgical procedure with potential risks. There is a clinical need for non-invasive biomarkers to facilitate early detection and spare patients from unnecessary surgery. The objective of this prospective cohort study is to evaluate the accuracy of plasma levels of Mir-141-3p and Mir-125b-5p as distinguishing biomarkers for patients with early-stage endometriosis. The study protocol involves the following procedures: - Clinical Screening: Women presenting with symptoms suggestive of EM (e.g., dysmenorrhea, pelvic pain, or infertility) are evaluated using the 30-item Endometriosis Health Profile (EHP-30) questionnaire. Biomarker Estimation: Blood samples are drawn to measure serum carbohydrate antigen (CA)-125 and the plasma expression levels of Mir-141-3p and Mir-125b-5p. Imaging: All participants undergo transvaginal ultrasound (TVS) to assess disease phenotype and grade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a clinical picture suggestive of Endometriosis (EM) disease.
- •Agreement to undergo the full study protocol, including staging laparoscopy.
排除标准
- •Presence of surgical scars hindering laparoscopy. Suspicion of malignancy or pregnancy. Body Mass Index (BMI) $> 30$ kg/m². Coagulopathies or autoimmune disorders.
研究组 & 干预措施
Group Early Endometriosis
This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility
干预措施: Staging Laparoscopy (Procedure)
Group Early Endometriosis
This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility
干预措施: Laboratory Biomarker Assessment (Mirs and CA-125) (Diagnostic Test)
Group Early Endometriosis
This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility
干预措施: Transvaginal Ultrasound (TVS) Staging (Diagnostic Test)
Group Deep Endometriosis
This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility
干预措施: Staging Laparoscopy (Procedure)
Group Deep Endometriosis
This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility
干预措施: Laboratory Biomarker Assessment (Mirs and CA-125) (Diagnostic Test)
Group Deep Endometriosis
This arm includes women who present with clinical manifestations suggestive of endometriosis (EM), such as dysmenorrhea, pelvic pain, or infertility
干预措施: Transvaginal Ultrasound (TVS) Staging (Diagnostic Test)
结局指标
主要结局
Diagnostic Sensitivity and Specificity of Plasma MicroRNA 125b-5p Fold Change for Differentiating Early Endometriosis
时间窗: 18 months
Evaluation of the diagnostic performance of plasma MicroRNA 125b-5p expression level (calculated as a fold-change relative to GAPDH using the $2\^{-\\Delta\\Delta CT}$ method). The outcome measures the diagnostic sensitivity and specificity of this single genetic biomarker at a pre-determined cutoff point of $\\ge 1.029$ to distinguish early endometriosis (laparoscopic Stages I-II) from deep endometriosis (laparoscopic Stages III-IV).
次要结局
未报告次要终点
研究者
Bassem Mohamed Talaat Abdelaziz Ali
Assistant Professor of Obestitrics and gynecology
Zagazig University