- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01950572
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
March 22, 2024 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.
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.
Study Overview
Status
Recruiting
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 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
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
- Name: Maria Garcia G Agra, R.N.
- Phone Number: (240) 858-3152
- Email: mariagracia.agra@nih.gov
Study Locations
-
-
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 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.
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
|
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
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.
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)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
January 24, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Neoplasms, Complex and Mixed
- Biliary Tract Diseases
- Pancreatic Diseases
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Thymus Neoplasms
- Neoplasms
- Stomach Neoplasms
- Thymoma
- Pancreatic Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Biliary Tract Neoplasms
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.
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