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OpenTrials
Completed

NCT Number: NCT00430053

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene rearrangement analysis

Genetic

polymerase chain reaction

Genetic

proteomic profiling

Genetic

flow cytometry

Other

immunohistochemistry staining method

Other

Biopsy

Procedure

Primary outcomes

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

  2. Provide a patient population for study by proteomic and molecular analysis

  3. Mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials

Secondary outcomes

  1. Develop a tissue bank for future disease study

  2. Offer a second opinion regarding treatment of CTCL and, in limited cases, provide standard-of-care treatment

  3. Develop an algorithm for screening and evaluating CTCL

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pathogenesis And Course Of Cutaneous T-Cell Lymphoma

Important dates

Study start
2004
Study completion
2010
First posted
Feb 1, 2007
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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