NCT01950572 Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
| NCT ID | NCT01950572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Thymoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2013-09-09 |
| Primary Completion | 2033-07-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2013-09-09 with a primary completion date of 2033-07-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. * 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....
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.
Contact & Investigator
Raffit Hassan, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT01950572 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 100 Years, studying Thymoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01950572 currently recruiting?
Yes, NCT01950572 is actively recruiting participants. Contact the research team at mariagracia.agra@nih.gov for enrollment information.
Where is the NCT01950572 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT01950572 clinical trial?
NCT01950572 is sponsored by National Cancer Institute (NCI). The principal investigator is Raffit Hassan, M.D. at National Cancer Institute (NCI). The trial plans to enroll 1,000 participants.