Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-09

Brief Summary

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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....

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Detailed Description

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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

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Mesothelioma Thymoma Pancreatic Neoplasms Biliary Tract Neoplasms Stomach Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1/Eligible cancer diagnosis

Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All participants greater than or equal to 2 years of age with malignant mesothelioma.
* All participants 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
* Ability and willingness of participant 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 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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No