Brief Title
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Official Title
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers
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 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.
Study Type
Observational
Primary Outcome
sample aquisition
Condition
Mesothelioma
Study Arms / Comparison Groups
1/Eligible cancer diagnosis
Description: Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1000
Start Date
September 9, 2013
Completion Date
July 11, 2034
Primary Completion Date
July 25, 2033
Eligibility 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
- Ability and willingness of subject 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.
Gender
All
Ages
2 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Raffit Hassan, M.D., (240) 858-3152, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01950572
Organization ID
130202
Secondary IDs
13-C-0202
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Raffit Hassan, M.D., Principal Investigator, National Cancer Institute (NCI)
Verification Date
January 12, 2021