ThymomaNCT01950572
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
An observational study of Thymoma and Stomach Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Thymoma, Stomach Neoplasms, Pancreatic Neoplasms
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2013to 25 Jul 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons with a diagnosis of any of the thoracic or GI cancers under study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Thymoma, Stomach Neoplasms, Pancreatic Neoplasms, Mesothelioma, Biliary Tract Neoplasms, Mesothelin Expressing Neoplasms
- Keywords
- Samples, Biobank, Lung Neoplasms, Ovarian Neoplasms, Natural History
- Medical subject headings
- Thymoma, Stomach Neoplasms, Pancreatic Neoplasms, Mesothelioma, Biliary Tract Neoplasms, Lung Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
sample aquisition
allow sample acquisition for use in the study of mesothelioma
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study start9 Sep 2013
- Primary completion25 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThymomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raffit Hassan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950572
- Sponsor's protocol ID
- 130202
- Other IDs
- 13-C-0202
- Status last verified
- 13 Oct 2026
- First submitted
- 21 Sep 2013
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31783178