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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430053
First Posted: February 1, 2007
Last Update Posted: March 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)
  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
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430053


Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark C. Udey, MD, PhD NCI - Dermatology Branch
  More Information

ClinicalTrials.gov Identifier: NCT00430053     History of Changes
Obsolete Identifiers: NCT00075322
Other Study ID Numbers: 040081
04-C-0081
CDR0000354510
First Submitted: January 30, 2007
First Posted: February 1, 2007
Last Update Posted: March 15, 2012
Last Verified: March 2012

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