Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma
NCT ID: NCT00430053
Last Updated: 2012-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2004-01-31
2010-06-30
Brief Summary
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PURPOSE: This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma.
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Detailed Description
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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
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Interventions
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gene rearrangement analysis
polymerase chain reaction
proteomic profiling
flow cytometry
immunohistochemistry staining method
biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health Clinical Center (CC)
NIH
Principal Investigators
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Mark C. Udey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NCI - Dermatology Branch
Locations
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Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
Countries
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Other Identifiers
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04-C-0081
Identifier Type: -
Identifier Source: secondary_id
CDR0000354510
Identifier Type: -
Identifier Source: secondary_id
040081
Identifier Type: -
Identifier Source: org_study_id
NCT00075322
Identifier Type: -
Identifier Source: nct_alias
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