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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00705809 |
Background:
Objectives:
-To implement a standardized epidemiologic questionnaire into the ongoing T-Cell Project to allow evaluation of various potential risk factors for PTLCs.
Eligibility:
-Untreated patients 18 years of age and older who were diagnosed with PTLC September 1, 2006, or later.
Design:
-Patients complete a questionnaire containing the following information:
Demographic information
Smoking history and alcohol use
Personal history or cancer
History of cancer among first-degree relatives
Medical history
History of transplants
History of blood transfusions
Medication use
Occupational and residential history
Pesticide treatment
-The information collected is linked to clinical and pathologic information in the T-Cell Project database.
Condition |
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Peripheral T-Cell Lymphoma |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | T-Cell Project: Epidemiologic Component |
Estimated Enrollment: | 800 |
Study Start Date: | June 2008 |
Peripheral T-cell lymphomas (PTCLs) comprise a heterogeneous group of neoplasms that are derived from post-thymic lymphoid cells at different stages of differentiation with different morphological patterns, phenotypes, and clinical presentations. Although a number of case-control studies on non-Hodgkin lymphoma (NHL) have identified various risk factors for disease, including autoimmune conditions, family history of hematopoietic malignancies, smoking, hepatitis C infection, and host susceptibility, these risk factors largely pertain to B-cell lymphoma subtypes as they comprise well over 90 percent of all NHLs. At present, there are no known epidemiologic risk factors for PTCL or its subtypes. This is largely due to the lack of sample size of PTCL in any one epidemiologic study. The aim of this proposal is to implement a standardized epidemiologic risk factor questionnaire into the on-going T-Cell Project. Briefly, the T-Cell Project is an international consortium of on-going clinical trials on peripheral PTCL. It serves as a prospective collection of patients (greater than 18 years) worldwide with PTCL who are enrolled at participating medical institutions for treatment in a clinical trial. The overall goal of the T-Cell Project is to improve current T-cell subtype classifications and to evaluate different treatment strategies for each T-cell subtype. The specific goal of our proposal is to implement, within the T-Cell Project, a 20-minute standardized epidemiologic questionnaire to allow evaluation of various potential risk factors for T-cell lymphomas. Importantly, there are currently no known epidemiologic risk factors for PTCL. We plan to administer questionnaires to 800 PTCL patients; if successful this collection would be the largest database of PTCLs to date with epidemiologic data. If the questionnaire implementation of assessing epidemiological risk factors for PTCL among patients in the T-Cell Project is found logistically feasible, then descriptive and analytic epidemiologic analyses of the collected data to understand the etiology of PTCL would be pursued at the NCI in collaboration with members of the T-Cell Project. For such analyses, NCI would receive only fully anonymized and de-linked data with no identifiers.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Contact: Sophia S. Wang, Ph.D. | (301) 402-5374 | wangso@mail.nih.gov |
United States, Maryland | |
National Cancer Institute (NCI), 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 999908163, 08-C-N163 |
Study First Received: | June 25, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00705809 |
Health Authority: | United States: Federal Government |
Epidemiology Peripheral T-Cell Lymphoma Peripheral T-Cell Lymphoma |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, T-Cell Lymphoma, Non-Hodgkin |
Lymphoproliferative Disorders Lymphoma, T-Cell, Peripheral Lymphoma Peripheral T-cell lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |