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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 : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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 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

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



Primary Outcome Measures :
  1. sample aquisition [ Time Frame: Ongoing ]
    allow sample acquisition for use in the study of mesothelioma



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.

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 (301) 594-1106 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)

Additional Information:
Publications:
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: March 2, 2018
Last Verified: February 23, 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