Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 2 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study collects and stores blood, urine, tumor tissue, and other body fluids to help researchers study mesothelioma, a cancer of the lining around some organs. It follows how the disease changes and records treatments received. It is for people age 2 or older with mesothelioma and adults with certain other 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 2 or older with mesothelioma; OR age 18 or older with one of the other eligible cancers.
- Other eligible cancers include cancer of the thymus, pancreas, bile ducts, lung, stomach, or ovary, or another solid tumor known to make a protein called mesothelin.
- The cancer diagnosis must be confirmed by lab testing of tissue or cells.
- Adults must be able and willing to give informed consent, meaning they understand and agree to join. A parent or guardian must give consent for anyone under age 18.
Who can't join
- A major organ illness with symptoms that makes a biopsy (taking a tissue sample) more risky. Examples include poor blood flow to the heart, a recent heart attack, heart failure, or lung problems.
- Pregnancy.
- Another current medical or mental health illness that may make joining unsafe, as judged by the lead study doctor.
- Adults who cannot give informed consent, as judged by the lead study doctor.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* 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 sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda