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

NCT00430053 | Completed

• 3 other identifiers: 04008104-C-0081CDR0000354510
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Interventions

gene rearrangement analysis GENETIC

polymerase chain reaction GENETIC

proteomic profiling GENETIC

flow cytometry OTHER

immunohistochemistry staining method OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Gene Rearrangement; Polymerase Chain Reaction; Flow Cytometry; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Genetic Phenomena; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Histocytochemistry; Histological Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Mark C. Udey, MD, PhD

  NCI - Dermatology Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: January 1, 2004
• Study Completion: June 1, 2010
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)