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Protocol Details

Tissue Procurement and Natural History Study of Patients with Malignant Mesothelioma and Other Mesothelin Expressing Cancers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-C-0202

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Adults who are or may become unable to consent

Keywords

Samples;
Biobank;
Lung Neoplasms;
Ovarian Neoplasms;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Mesothelioma;
Thymoma;
Pancreatic Neoplasms;
Biliary Tract Neoplasms;
Stomach Neoplasms

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Raffit Hassan, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5330
10 CENTER DR
BETHESDA MD 20892
(240) 760-6232
rh276q@nih.gov

Maria Gracia L. Agra, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D44
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3152
mariagracia.agra@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT01950572

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