NCT01950572

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: * All patients age greater than or equal to 2 years with malignant mesothelioma * 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.

Detailed description

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: * All participants age greater than or equal to 2 years with malignant mesothelioma * All participants age greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers * 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 participants under the age of 18 Design: * Up to 1000 participants will be enrolled. * Participants will be followed to determine the course of disease and to record any treatment received for the eligible mesothelin expressing cancer. * Participants 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.

Conditions

• Mesothelioma
• Thymoma
• Pancreatic Neoplasms
• Biliary Tract Neoplasms
• Stomach Neoplasms

Timeline

• Start date: 2013-09-09
• Primary completion: 2033-07-25
• First posted: 2013-09-25
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States