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Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01950572
First received: September 21, 2013
Last updated: July 19, 2014
Last verified: June 2014
  Purpose

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
Mesothelioma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Allow sample acquisition for use in the study of mesothelioma [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2013
Estimated Study Completion Date: July 2034
Estimated Primary Completion Date: July 2034 (Final data collection date for primary outcome measure)
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.

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • All patients with malignant mesothelioma.
  • Confirmed pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis.
  • Age greater than or equal to2years
  • Ability and willingness of subject or legally authorized representative (LAR) 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.
  • Recruitment strategies:

    • All patients who are screened for treatment protocols or who seek second opinions in the mesothelioma clinic of the NCI will be screened for this protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950572

Contacts
Contact: Lisa A Bengtson, R.N. (301) 435-5398 bengtsonla@mail.nih.gov
Contact: Raffit Hassan, M.D. (301) 451-8742 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
Investigators
Principal Investigator: Raffit Hassan, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01950572     History of Changes
Other Study ID Numbers: 130202, 13-C-0202
Study First Received: September 21, 2013
Last Updated: July 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Samples
Biobank
Pleural Mesothelioma
Peritoneal Mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on July 26, 2014