Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

June 4, 2026 updated by: National Cancer Institute (NCI)

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

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.

Objectives:

-To allow sample acquisition for use in the study of mesothelioma.

Eligibility:

  • All participants age greater than or equal to 2 years with malignant mesothelioma OR
  • All participants greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin
  • 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.

Study Overview

Status

Recruiting

Conditions

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 participants age >= 2 years with malignant mesothelioma
  • All participants age >= 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin
  • 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 participants under the age of 18

Design:

  • Up to 1000 participants will be enrolled.
  • Participants will be followed to determine the course of disease and to record any treatment received for the eligible mesothelin expressing cancer.
  • Participants 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

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Raffit Hassan, M.D.
  • Phone Number: (240) 760-6232
  • Email: rh276q@nih.gov

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

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.

Description

  • INCLUSION CRITERIA:
  • All participants >= 2 years of age with malignant mesothelioma.
  • All participants >=18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin.
  • Confirmed pathological diagnosis is required
  • Ability and willingness of participant 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1/Eligible cancer diagnosis
Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sample aquisition
Time Frame: Ongoing
allow sample acquisition for use in the study of mesothelioma
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2013

Primary Completion (Estimated)

July 25, 2033

Study Registration Dates

First Submitted

September 21, 2013

First Submitted That Met QC Criteria

September 21, 2013

First Posted (Estimated)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

May 29, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130202
  • 13-C-0202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stomach Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe