NCT00020072

Brief Summary

RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing better methods to detect, predict, and treat cutaneous T-cell lymphoma. PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 29, 2015

Status Verified

March 1, 2003

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

Lymphoma

Keywords

cutaneous T-cell non-Hodgkin lymphomamycosis fungoides/Sezary syndrome

Interventions

laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven mycosis fungoides with 2 or more plaques or tumors greater than 1 cm in size OR * Immunologically proven Sezary syndrome with all of the following: * Erythroderma * Lymphadenopathy * T-cell receptor variable beta chain clonality greater than 10% of total lymphocytes by flow cytometry OR * CD4+CD7- T-cell fraction that represents greater than 10% of CD4+ T cells PATIENT CHARACTERISTICS: Age: * 18 to 85 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * HIV-1 and HTLV-1 negative * No prior intravenous drug use PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 2 months since prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 2 months since prior electron beam radiotherapy Surgery: * Not specified Other: * At least 2 weeks since prior topical therapy * At least 2 months since prior photopheresis * At least 2 months since prior psoralen ultraviolet light (PUVA) or ultraviolet B (UVB) therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • Hwang ST, Fitzhugh DJ. Aberrant expression of adhesion molecules by Sezary cells: functional consequences under physiologic shear stress conditions. J Invest Dermatol. 2001 Mar;116(3):466-70. doi: 10.1046/j.1523-1747.2001.01282.x.

    PMID: 11231324RESULT

MeSH Terms

Conditions

LymphomaLymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Study Officials

  • Sam T. Hwang, MD, PhD

    NCI - Dermatology Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 2000

Last Updated

April 29, 2015

Record last verified: 2003-03

Locations

US(1)