NCT00430053

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

Pathogenesis And Course Of Cutaneous T-Cell Lymphoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
GENETIC	gene rearrangement analysis
GENETIC	polymerase chain reaction
GENETIC	proteomic profiling
OTHER	flow cytometry
OTHER	immunohistochemistry staining method
PROCEDURE	biopsy

Timeline

• Start date: 2004-01-01
• Completion: 2010-06-01
• First posted: 2007-02-01
• Last updated: 2012-03-15

Locations

1 site across 1 country: United States