Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
- Conditions
- MesotheliomaThymomaStomach NeoplasmsPancreatic NeoplasmsBiliary Tract Neoplasms
- Registration Number
- NCT01950572
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sample aquisition Ongoing allow sample acquisition for use in the study of mesothelioma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States