NCT00986206已完成不适用
Development of an Assay for the Early Detection of Ovarian Cancer.
Women and Infants Hospital of Rhode Island1 个研究点 分布在 1 个国家目标入组 525 人开始时间: 2009年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 525
- 试验地点
- 1
- 主要终点
- Validation of a new assay for lysophosphatidic acid (LPA)
研究概览
简要总结
RATIONALE: Screening tests, such as the lysophosphatidic acid assay, may help doctors find cancer cells early and plan better treatment for ovarian cancer.
PURPOSE: This clinical trial is studying using the lysophosphatidic acid assay to see how well it works in early detection of ovarian cancer in patients with ovarian cancer or who are at risk for ovarian cancer.
详细描述
OBJECTIVES:
Primary
- To validate a new assay for lysophosphatidic acid (LPA) in early detection of ovarian cancer.
Secondary
- To estimate the risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women presenting with a pelvic mass and compare LPA results from both surgical patient groups with those from "normal", disease-free women at high-risk of ovarian cancer.
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 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible Patients
- •Patients age ≥ 21 years
- •Patients with a diagnosis of a pelvic mass (defined as a simple, complex or a solid ovarian / pelvic mass) who are scheduled to undergo surgery.
- •Patients with a new diagnosis of epithelial ovarian carcinoma undergoing primary chemotherapy treatment.
- •Patients with a history of epithelial ovarian carcinoma status post primary chemotherapy treatment, currently in clinical remission.
- •Patients with a known BRCA mutation and who have NOT undergone a bilateral salpingo-oophorectomy.
- •Clinical remission should require all of following:
- •Absence of symptoms that may be related to disease;
- •Imaging without abnormalities greater then or equal to 1 cm suspicious for disease (no ascites);
- •CA 125 obtained x 2 at least 3 weeks apart and not increasing by 50% and < 40 units/mL.
- •Patients must have signed an approved informed consent and authorization permitting release of personal health information.
- •Women of childbearing potential must have a negative pregnancy test. They as well as their partners must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
排除标准
- •Ineligible Patients
- •Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients with synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded, unless all of the following conditions are met: Stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions.
- •Patients with epithelial ovarian carcinoma of low malignant potential (Borderline carcinomas).
- •Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or have received chemotherapy for another malignancy.
- •Patients of any stage who have recurred and are in second chemotherapy induced remission.
- •Patients with septicemia, severe infection, or acute hepatitis.
- •Patients who are pregnant or lactating.
结局指标
主要结局
Validation of a new assay for lysophosphatidic acid (LPA)
时间窗: 5 years
To develop a serum or plasma based assay to quantitate LPA levels
次要结局
- Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women(5 years)
- LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer(5 years)
研究者
Richard G. Moore, MD
Gynecologic Oncologist
Women and Infants Hospital of Rhode Island
研究点 (1)
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