Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma
This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00430053
First received: January 30, 2007
Last updated: March 14, 2012
Last verified: March 2012
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Purpose
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 | Intervention |
|---|---|
|
Lymphoma |
Genetic: gene rearrangement analysis Genetic: polymerase chain reaction Genetic: proteomic profiling Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy |
| Study Type: | Observational |
| Official Title: | Pathogenesis And Course Of Cutaneous T-Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2010 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430053
Locations
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Mark C. Udey, MD, PhD | NCI - Dermatology Branch |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00430053 History of Changes |
| Obsolete Identifiers: | NCT00075322 |
| Other Study ID Numbers: | 040081, 04-C-0081, CDR0000354510 |
| Study First Received: | January 30, 2007 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 16, 2013