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| Sponsor: | National Institutes of Health Clinical Center (CC) |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00430053 |
Purpose
RATIONALE: Gathering information about patients with cutaneous T-cell lymphoma over time may help doctors learn more about the disease.
PURPOSE: This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Genetic: gene rearrangement analysis Genetic: polymerase chain reaction Genetic: proteomic profiling Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy |
| Study Type: | Observational |
| Official Title: | Pathogenesis And Course Of Cutaneous T-Cell Lymphoma |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2010 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo disease assessment by physical examination, full-body photographic documentation of skin disease, biopsy, and blood sampling at baseline and then at least annually thereafter. Proteomic and molecular methods are used to analyze samples. Biopsies may be examined using histologic and immunohistochemical methods. Blood may be analyzed by polymerase chain reaction for clonal T-cell gene rearrangements or by flow cytometry.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | Mark C. Udey, MD, PhD | NCI - Dermatology Branch |
More Information
| ClinicalTrials.gov Identifier: | NCT00430053 History of Changes |
| Obsolete Identifiers: | NCT00075322 |
| Other Study ID Numbers: | 040081, 04-C-0081, CDR0000354510 |
| Study First Received: | January 30, 2007 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government |
|
stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma |
stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome |
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |