Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Follow the disease course of patients with cutaneous T-cell lymphoma. Provide a patient population for study by proteomic and molecular analysis. Develop a mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials. Secondary Develop a tissue bank for future disease study using specimens from these patients. Provide community outreach by offering a second opinion regarding treatment of this disease in these patients and, in limited cases, provide standard-of-care treatment to these patients. Develop an algorithm for screening and evaluating this disease in these patients. 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.

Official Title
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Pathogenesis And Course Of Cutaneous T-Cell Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Genetic: gene rearrangement analysis
* Genetic: polymerase chain reaction
* Genetic: proteomic profiling
* Other: flow cytometry
* Other: immunohistochemistry staining method
* Procedure: biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Histologically confirmed stage IA-IVB cutaneous T-cell lymphoma (CTCL) (mycosis fungoides or Sézary syndrome) Other histologically and clinically confirmed primary or secondary CTCL Histologically and clinically confirmed pre-CTCL skin condition, including large plaque parapsoriasis and lymphomatoid papulosis Measurable disease by skin lesion assessment or Sézary cell count PATIENT CHARACTERISTICS: Age Over 18 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Human T-cell lymphotrophic virus (HTLV) I/II negative Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene rearrangement analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: proteomic profiling|nan|
|Other: flow cytometry|nan|
|Other: immunohistochemistry staining method|nan|
|Procedure: biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease course of patients with cutaneous T-cell lymphoma (CTCL) |  |  | 
| Provide a patient population for study by proteomic and molecular analysis |  |  | 
| Mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop a tissue bank for future disease study |  |  | 
| Offer a second opinion regarding treatment of CTCL and, in limited cases, provide standard-of-care treatment |  |  | 
| Develop an algorithm for screening and evaluating CTCL |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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