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

Completed

• Conditions: Lymphoma

• Registration Number: NCT00430053
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-30
• Study First Posted: 2007-02-01
• Study Completion: 2010-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States