Clinical trial NCT01950572: Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Official title: Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mesothelioma
Thymoma
Pancreatic Neoplasms
Biliary Tract Neoplasms
Stomach Neoplasms
Keywords: Samples
Biobank
Lung Neoplasms
Ovarian Neoplasms
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2013-09-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with a diagnosis of any of the thoracic or GI cancers under study.

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.

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....

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 greater than or equal to 2 years with malignant mesothelioma
* All participants 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 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.

Eligibility criteria: * INCLUSION CRITERIA:
* All participants greater than or equal to 2 years of age with malignant mesothelioma.
* All participants 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 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.

Primary outcomes:
measure: sample aquisition
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Raffit Hassan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.