NCT01950572招募中不适用
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- sample aquisition
研究概览
简要总结
Background:
- Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.
- Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.
- The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.
- Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.
- In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma.
Objectives:
-To allow sample acquisition for use in the study of mesothelioma.
Eligibility:
- All participants age greater than or equal to 2 years with malignant mesothelioma OR
- All participants greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin
- Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18
Design:
- Up to 1000 subjects will be enrolled.
- Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma.
- Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.
- Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.
详细描述
Background:
- Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.
- Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.
- The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.
- Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.
- In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma.
- Mesothelin expression level has been correlated with improved overall survival in thymic cancer and with reduced overall survival in patients with lung cancer.
Objective:
-To allow sample acquisition for use in the study of mesothelioma and other mesothelin expressing cancers.
Eligibility:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •All participants >= 2 years of age with malignant mesothelioma.
- •All participants >=18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin.
- •Confirmed pathological diagnosis is required
- •Ability and willingness of participant to provide informed consent to participation.
排除标准
- •Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
- •Pregnant women.
- •Active concomitant medical or psychological illnesses that may increase the risk to the participant or in adult participants, inability to obtain informed consent, at the discretion of the principal investigator.
研究组 & 干预措施
1/Eligible cancer diagnosis
Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin
结局指标
主要结局
sample aquisition
时间窗: Ongoing
allow sample acquisition for use in the study of mesothelioma
次要结局
未报告次要终点
研究者
研究点 (1)
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