Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Maria Gracia L Agra, R.N.
mariagracia.agra@nih.gov
(240) 858-3152
Backup
Raffit Hassan, M.D.
rh276q@nih.gov
(240) 760-6232
Time Frame
Start Date: 2013-09-09
Estimated Completion Date: 2033-07-25
Participants
Target number of participants: 1000
Treatments
1/Eligible cancer diagnosis
Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov