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

National Institutes of Health Clinical Center (CC)

Status: Completed

Conditions: Lymphoma

Treatments: Genetic: polymerase chain reaction; Other: immunohistochemistry staining method; Genetic: gene rearrangement analysis; Genetic: proteomic profiling; Other: flow cytometry; Procedure: biopsy

Study type: Observational

Funder types: NIH

Identifiers

NCT00430053

CDR0000354510

04-C-0081

040081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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