Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Conditions
Mesothelioma
Conditions: official terms
Lung Neoplasms - Mesothelioma
Conditions: Keywords
Samples, Biobank, Pleural Mesothelioma, Peritoneal Mesothelioma
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
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.

Objectives:

-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 2 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 2 Years
Gender: Both
Criteria: - INCLUSION CRITERIA:

- All patients greater than or equal to 2 years of age with malignant mesothelioma.

- All patients greater than or equal to18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers.

- Confirmed pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis.

- Age greater than or equal to2years

- Ability and willingness of subject or legally authorized representative (LAR) to provide informed consent to participation.

EXCLUSION CRITERIA:

- 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 or breast feeding women will be eligible for this protocol, but will not undergo tumor biopsy.

- Active concomitant medical or psychological illnesses that may increase the risk to the subject or in adult patients, inability to obtain informed consent, at the discretion of the principal investigator.

- Recruitment strategies:

- All patients who are screened for treatment protocols or who seek second opinions in the mesothelioma clinic of the NCI will be screened for this protocol.
Location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Status: Recruiting
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office - 888-624-1937
Start Date
September 2013
Completion Date
July 2034
Sponsors
National Cancer Institute (NCI)
Source
National Institutes of Health Clinical Center (CC)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page