Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00430053|
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : March 15, 2012
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 or disease||Intervention/treatment|
|Lymphoma||Genetic: gene rearrangement analysis Genetic: polymerase chain reaction Genetic: proteomic profiling Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy|
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Pathogenesis And Course Of Cutaneous T-Cell Lymphoma|
|Study Start Date :||January 2004|
|Study Completion Date :||June 2010|
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430053
|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|