Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01950572 |
| Other study ID # |
130202 |
| Secondary ID |
13-C-0202 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2013 |
Study information
| Verified date |
January 24, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
Maria Garcia G Agra, R.N. |
| Phone |
(240) 858-3152 |
| Email |
mariagracia.agra[@]nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
