Lymphoma
Conditions
Keywords
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
Brief summary
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
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.
Interventions
GENETICgene rearrangement analysis
GENETICpolymerase chain reaction
GENETICproteomic profiling
OTHERflow cytometry
OTHERimmunohistochemistry staining method
PROCEDUREbiopsy
Sponsors
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
United States
Outcome results
None listed