NCT03943316招募中不适用
Single Institution (UNM) Prospective Laboratory Study of Cancer and Immune Cells in the Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis
研究概览
简要总结
Ascites samples from women undergoing surgery for ovarian cancer will be collected for use in translational research.
详细描述
The purpose of this study is to collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis at the University of New Mexico Hospital or Cancer Center. Cancer cells and immune cells from the ascites fluid will be used to test novel immunotherapies for ovarian cancer treatment and to establish patient derived xenograft models to perform preclinical testing on a cancer cell population that better models the heterogeneity in patient disease
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •All female participants, regardless of ethnicity, who are undergoing cytoreductive surgery for ovarian cancer are eligible for this study
- •All participants will be eighteen years old or older
- •Patients must be suspected of having a pathological diagnosis or clinical suspicion of ovarian cancer and be scheduled for surgery for tumor resection.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Pathologic confirmation of a diagnosis of epithelial adenocarcinoma of the ovary, fallopian tube, or primary peritoneal cancer (serous, mucinous, clear cell, endometrioid, undifferentiated, mixed, transitional cell)
- •Women of childbearing potential must have a negative qualitative serum pregnancy test ≤ 2 weeks prior to study entry.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
排除标准
- •We do not intend to include participants if they are unable to provide informed consent for this study themselves (e.g. mentally ill patients who require health care proxies to consent for any medical intervention), or vulnerable populations such as prisoners.
- •Minors under age eighteen.
- •Pregnant women.
- •Final pathologic diagnosis that does not confirm invasive epithelial ovarian, tubal, or primary peritoneal cancer
结局指标
主要结局
Collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis
时间窗: 5 years
To elucidate the conditions of the tumor environment that contribute to cancer dissemination in the peritoneal cavity through ex vivo evaluation of malignant ascites collected from women with ovarian, tubal, or primary peritoneal cancer.
次要结局
- To correlate specific features of peritoneal cell populations or soluble factors with patient outcome.(5 years)
研究者
研究点 (1)
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