Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
2 other identifiers
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2013
CompletedFirst Submitted
Initial submission to the registry
September 21, 2013
CompletedFirst Posted
Study publicly available on registry
September 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2033
ExpectedApril 9, 2026
April 3, 2026
19.9 years
September 21, 2013
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sample aquisition
allow sample acquisition for use in the study of mesothelioma
Ongoing
Study Arms (1)
1/Eligible cancer diagnosis
Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers
Eligibility Criteria
Persons with a diagnosis of any of the thoracic or GI cancers under study.
You may qualify if:
- 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.
You may not qualify if:
- 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 women
- Active concomitant medical or psychological illnesses that may increase the risk to the participant or in adult participants, inability to obtain informed consent, at the discretion of the principal investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Mian I, Abdullaev Z, Morrow B, Kaplan RN, Gao S, Miettinen M, Schrump DS, Zgonc V, Wei JS, Khan J, Pack S, Hassan R. Anaplastic Lymphoma Kinase Gene Rearrangement in Children and Young Adults With Mesothelioma. J Thorac Oncol. 2020 Mar;15(3):457-461. doi: 10.1016/j.jtho.2019.11.011. Epub 2019 Nov 26.
PMID: 31783178DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raffit Hassan, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2013
First Posted
September 25, 2013
Study Start
September 9, 2013
Primary Completion (Estimated)
July 25, 2033
Last Updated
April 9, 2026
Record last verified: 2026-04-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data in BTRIS will be shared throughout the course of the study and indefinitely with the permission of the investigator.@@@@@@Genomic data will be shared from the time of upload to genomic database.
- Access Criteria
- Clinical IPD will be shared through the BTRIS database for open ended analysis. All BTRIS subscribers, generally limited to the NIH Clinical Center, may request data.@@@@@@Genomic IPD will be shared through dbGaP, per rules of the database, for purposes of genomic analysis.
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.