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| ID | Type | Description | Link |
|---|---|---|---|
| 04-C-0081 | |||
| CDR0000354510 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene rearrangement analysis | Genetic | |||
| polymerase chain reaction | Genetic | |||
| proteomic profiling | Genetic | |||
| flow cytometry | Other | |||
| immunohistochemistry staining method | Other | |||
| biopsy | Procedure |
| 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 |
| 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 | ||
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Measurable disease by skin lesion assessment or Sézary cell count
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Mark C. Udey, MD, PhD | NCI - Dermatology Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | 20892-1182 | United States |
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| Develop an algorithm for screening and evaluating CTCL |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D015321 | Gene Rearrangement |
| D016133 | Polymerase Chain Reaction |
| D005434 | Flow Cytometry |
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D055614 | Genetic Phenomena |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D006651 | Histocytochemistry |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
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