Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

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ClinicalTrials.gov Identifier: NCT01950572

Recruitment Status : Recruiting

First Posted : September 25, 2013

Last Update Posted : August 20, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description

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.

Condition or disease
Mesothelioma Thymoma Pancreatic Neoplasms Biliary Tract Neoplasms Stomach Neoplasms

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 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.

Study Design


Study Type :	Observational
Estimated Enrollment :	1000 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers
Study Start Date :	September 21, 2013
Estimated Primary Completion Date :	December 31, 2030
Estimated Study Completion Date :	December 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Stomach Cancer Malignant Mesothelioma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1/Eligible cancer diagnosis Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers

Outcome Measures

Primary Outcome Measures :

sample aquisition [ Time Frame: Ongoing ]
allow sample acquisition for use in the study of mesothelioma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years to 100 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Persons with a diagnosis of any of the thoracic or GI cancers under study.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950572

Contacts


Contact: Maria Agra	(240) 858-3152	mariagracia.agra@nih.gov
Contact: Raffit Hassan, M.D.	(240) 760-6232	rh276q@nih.gov

Locations


United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Raffit Hassan, M.D.	National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Tsiouris A, Walesby RK. Malignant pleural mesothelioma: current concepts in treatment. Nat Clin Pract Oncol. 2007 Jun;4(6):344-52. Review.

Price B, Ware A. Time trend of mesothelioma incidence in the United States and projection of future cases: an update based on SEER data for 1973 through 2005. Crit Rev Toxicol. 2009;39(7):576-88. doi: 10.1080/10408440903044928. Review.

Bridda A, Padoan I, Mencarelli R, Frego M. Peritoneal mesothelioma: a review. MedGenMed. 2007 May 10;9(2):32. Review.


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01950572 History of Changes
Other Study ID Numbers:	130202 13-C-0202
First Posted:	September 25, 2013 Key Record Dates
Last Update Posted:	August 20, 2018
Last Verified:	July 27, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):


Samples Biobank Lung Neoplasms Ovarian Neoplasms

Additional relevant MeSH terms:


Neoplasms Mesothelioma Pancreatic Neoplasms Stomach Neoplasms Thymoma Biliary Tract Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Digestive System Neoplasms Neoplasms by Site	Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gastrointestinal Neoplasms Gastrointestinal Diseases Stomach Diseases Neoplasms, Complex and Mixed Thymus Neoplasms Thoracic Neoplasms Lymphatic Diseases Biliary Tract Diseases

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