Diagnostic Utility of Culdocentesis in Patients with a Suspicious Adnexal Mass

尾根穿刺术在可疑附件肿块患者中的诊断效用

• 批准号: 8621175
• 负责人: LAURENT BRARD
• 金额: $ 7.38万
• 依托单位: SOUTHERN ILLINOIS UNIVERSITY SCH OF MED
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-12-13 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8621175
• 关键词: Abdomen; Address; Adnexal Mass; Affect; Anxiety; Aspirate substance; Benign; Bilateral; Bilateral oophorectomy; Biological Markers; CA-125 Antigen; Cells; Clinic; Clinical; Clinical Data; Collection; Consent; Cortex of ovary; Cyst; Cytology; Detection; Diagnosis; Diagnostic; Diagnostic Procedure; Diffusion; Disease; Early Diagnosis; Early Intervention; Endometrial Carcinoma; Enrollment; Epididymis; Epithelial ovarian cancer; FDA approved; Goals; Greater sac of peritoneum; Gynecologic; Gynecology; Health; Human; Hysterectomy; Investigation; Laparoscopy; Laparotomy; Lead; Localized Disease; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of ovary; Measurable; Measurement; Measures; Menopausal Status; Methods; Modality; Monitor; Morbidity - disease rate; Neoadjuvant Therapy; Operative Surgical Procedures; Outcome; Outpatients; Ovarian Carcinoma; Ovariectomy; Ovary; Pathology; Patients; Pattern; Pelvis; Peritoneal; Peritoneal Fluid; Peritoneum; Physicians; Pilot Projects; Procedures; Prospective Studies; Proteins; Recruitment Activity; Recurrence; Reporting; Research; Research Design; Risk; Route; Saline; Salpingo-Oophorectomy; Sampling; Schedule; Sensitivity and Specificity; Serum; Staging; Survival Rate; Symptoms; Techniques; Therapeutic; Triage; Tumor Debulking; Tumor Markers; Urine; Woman; base; cancer cell; cancer diagnosis; chemotherapy; cost; effective therapy; high risk; improved; innovation; intraperitoneal; minimally invasive; mortality; novel; novel strategies; public health relevance; response; screening; socioeconomics; tool; tumor

DESCRIPTION (provided by applicant): Epithelial ovarian cancer (EOC) is the most lethal gynecologic malignancy. Nearly 10 million women in the US are at high risk for EOC with greater than 21,000 new annual diagnoses. Over 60% of diagnosed patients have advanced stage EOC, with a five-year survival rate less than 30%, compared to over 90% five-year survival for localized disease. Stage I EOC is difficult to detect amid non-specific symptoms that delay workup until a pelvic mass is found. Once an adnexal mass is found, the current diagnostic armamentarium includes sonographic grading of the tumor and analyzing serum levels of tumor markers, Cancer Antigen 125 [CA-125] and Human epididymis protein 4 [HE4]. HE4 is reported to be the most sensitive biomarker for detecting stage I EOC, while elevated serum levels of CA-125 (e 35 U/mL) alone lack adequate sensitivity and specificity for a definitive diagnosis. HE4, measurable in urine, to our knowledge, has not been measured in peritoneal fluid, although culdocentesis has been a useful technique in the field of gynecology for many years and can be performed in an outpatient setting. A minimally invasive, reliable diagnostic tool is needed for poor surgical candidates to avoid an oophorectomy for benign disease that could result in unnecessary morbidity. Specific Aim: To determine if levels of tumor markers (CA-125 and HE4) and cytology from peritoneal washings obtained via the cul-de-sac correlate with a diagnosis of epithelial ovarian cancer. We hypothesize that measuring these markers in combination from peritoneal fluid may increase the sensitivity to the presence of cancer cells beyond the ovarian cortex which may result in earlier detection of EOC. Study design: The prospective study will recruit and consent a convenience sampling of 60 women scheduled for surgical staging of a suspicious adnexal mass. Surgical staging of endometrial and ovarian carcinomas includes the collection of peritoneal washings. Our innovative technique differs from standard culdocentesis by infusing saline into the cul-de-sac and re-aspirating for collection (i.e. peritoneal washings). Cytology of peritoneal aspirations will be analyzed along with levels of tumor markers, CA-125 and HE4. Relevance: Our research goal is to develop a simple, non-surgical diagnostic tool that could reliably identify EOC prior to surgical staging. Th decision to undergo an oophorectomy for benign disease may result in unnecessary morbidity in patients who are poor surgical candidates. Study results could change the current clinical paradigm: operative management of a potentially benign tumor to avoid delayed surgical intervention of a potential malignancy. The proposed efforts will, at the very least, help answer the potential utility of clinic- based, non-surgical culdocentesis in pelvic mass triaging and ovarian cancer diagnosis. A minimally invasive, reliable diagnostic tool would improve early detection and, therefore, patient survival rates for EOC.

描述（由申请人提供）：上皮卵巢癌（EOC）是最致命的妇科恶性肿瘤。美国近1000万妇女的EOC风险高21,000多个新的年度诊断。超过60％的被诊断患者患有EOC，五年生存率低于30％，而局部疾病的五年生存率则超过90％。 I阶段EOC很难在非特异性症状中检测到，这些症状延迟了工作，直到发现骨盆肿块。一旦发现了附加质量，当前的诊断臂臂包括肿瘤的超声分级，并分析肿瘤标记的血清水平，癌症抗原125 [CA-125]和人类附子蛋白4 [HE4]。据报道，HE4是检测I期EOC的最敏感的生物标志物，而仅CA-125（E 35 U/mL）的血清水平升高缺乏适当的灵敏度和特异性，无法获得明确的诊断。据我们所知，在尿液中可测量的HE4在腹膜液中尚未测量，尽管多年来塞尔迪穿刺术一直是妇科领域的有用技术，并且可以在门诊环境中进行。对于不良的手术候选者需要一种微创，可靠的诊断工具，以避免良性疾病的卵巢切除术，这可能导致不必要的发病率。具体目的：确定通过CUL-DE-SAC获得的腹膜洗涤水平（CA-125和HE4）的水平（CA-125和HE4）和细胞学是否与上皮卵巢癌的诊断相关。我们假设通过腹膜液来测量这些标记物可能会增加对卵巢皮层以外的癌细胞存在的敏感性，这可能会导致EOC的早期检测。研究设计：前瞻性研究将招募和同意60名女性计划进行可疑附件质量的手术分期的便利抽样。子宫内膜和卵巢癌的手术分期包括收集腹膜洗涤物。我们的创新技术通过将盐水注入CUL-DE-SAC并重新吸收收集（即腹膜洗涤），这与标准的Culdocentesis不同。腹膜抽吸的细胞学将与肿瘤标记物（CA-125和HE4）的水平一起进行分析。相关性：我们的研究目标是开发一种简单，非手术的诊断工具，该工具可以在手术分期之前可靠地识别EOC。决定接受良性疾病的卵巢切除术可能导致手术不良候选患者不必要的发病率。研究结果可能会改变当前的临床范例：对潜在良性肿瘤的手术管理，以避免潜在恶性肿瘤的手术干预延迟。拟议的努力至少将有助于回答骨盆质量分域和卵巢癌诊断中临床基于诊所的非外科穿刺性的潜在效用。一种微创，可靠的诊断工具将改善EOC的早期检测，因此会改善患者的存活率。