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

Lymphoma Clinical Trial

Official title:

Pathogenesis And Course Of Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430053
• Other study ID #: 040081
• Secondary ID: 04-C-0081CDR0000
• Status: Completed
• Phase: N/A
• First received: January 30, 2007
• Last updated: March 14, 2012
• Start date: January 2004
• Est. completion date: June 2010

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00075322

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

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

Intervention

Genetic:
• gene rearrangement analysis

• polymerase chain reaction

• proteomic profiling

Other:
• flow cytometry

• immunohistochemistry staining method

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease course of patients with cutaneous T-cell lymphoma (CTCL)
Primary	Provide a patient population for study by proteomic and molecular analysis
Primary	Mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials
Secondary	Develop a tissue bank for future disease study
Secondary	Offer a second opinion regarding treatment of CTCL and, in limited cases, provide standard-of-care treatment
Secondary	Develop an algorithm for screening and evaluating CTCL