search
Back to results

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

Primary Purpose

Lymphoma

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
gene rearrangement analysis
polymerase chain reaction
proteomic profiling
flow cytometry
immunohistochemistry staining method
biopsy
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

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

Full Information

First Posted
January 30, 2007
Last Updated
March 14, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00430053
Brief Title
Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma
Official Title
Pathogenesis And Course Of Cutaneous T-Cell Lymphoma
Study Type
Observational

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
gene rearrangement analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
proteomic profiling
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
biopsy
Primary Outcome Measure Information:
Title
Disease course of patients with cutaneous T-cell lymphoma (CTCL)
Title
Provide a patient population for study by proteomic and molecular analysis
Title
Mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials
Secondary Outcome Measure Information:
Title
Develop a tissue bank for future disease study
Title
Offer a second opinion regarding treatment of CTCL and, in limited cases, provide standard-of-care treatment
Title
Develop an algorithm for screening and evaluating CTCL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C. Udey, MD, PhD
Organizational Affiliation
NCI - Dermatology Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs