Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Pancreatic Neoplasms Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 patients age greater than or equal to 2 years with malignant mesothelioma

• All patients 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 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 the eligible mesothelin expressing cancer.

• 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01950572
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Maria Gracia L Agra, R.N.
• Phone: (240) 858-3152
• Email: mariagracia.agra@nih.gov
• Status: Recruiting
• Start date: September 9, 2013