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Pathogenesis And Course Of Cutaneous T-Cell Lymphoma


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Pathogenesis And Course Of Cutaneous T-Cell Lymphoma


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Disease course of patients with cutaneous T-cell lymphoma (CTCL)

Principal Investigator

Mark C. Udey, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Dermatology Branch

Authority:

United States: Federal Government

Study ID:

040081

NCT ID:

NCT00430053

Start Date:

January 2004

Completion Date:

June 2010

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182