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OpenTrials
Completed

NCT Number: NCT02836886

VircapSeq Virus Detection in Sézary Syndrome

This study will be using this technique, called "VirCapSeq-VERT" to analyze the white blood cells of patients with Sézary syndrome. This could provide the foundation for future studies looking to understand the role that viruses play in the origin of Sézary syndrome. This could have important implications for the future development of new and effective therapies for the disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

Cutaneous T-cell lymphoma (CTCL) is a rare lymphoproliferative disorder characterized by malignant CD4+ T-cells that infiltrate the skin. While most cases are confined to skin, CTCL is also capable of affecting the blood, lymph nodes, and visceral organs. Sézary Syndrome (SS) is a leukemic variant of the disease with a poor prognosis and can arise with or without cutaneous involvement. The pathogenesis of CTCL is poorly understood, but chronic antigen stimulation possibly due to a bacterial or viral infection or colonization of the skin may lead to malignant transformation of the skin resident T cells. Colonization of the skin of CTCL patients with Staphylococcus aureus is common and can lead to the clonal expansion of malignant T cells in the skin. However, its role as an etiological agent is unlikely, considering commonality of S.aureus and rarity of the skin T-cell lymphomas. Mounting evidence suggests that oncogenic viral pathogen may play a role, but all efforts to implicate certain viruses, such as retroviruses or herpesviruses have yielded inconsistent results. This study will use the most sensitive method to date, a novel viral detection technique capable of detecting every known vertebrate virus in tissue samples, called "Virome Capture Sequencing Platform for Vertebrate Viruses (VirCapSeq-VERT)." This allows it to detect previously undiscovered viruses that diverge from known sequences by as much as 40%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Sézary syndrome diagnosed according to the WHO-EORTC classification.

Exclusion criteria

  • Pregnant patients.
  • Patients with known anemia with documented <7.5 mg/dL.
  • Patients who are unable to give informed consent.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome

    Time frame: Through study completion, an average of 4 months

Other outcomes

  1. Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome

    Time frame: Through study completion, an average of 4 months

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Searching for Oncogenic Viruses in Sézary Cells Using a Novel Viral Discovery Technique, VirCapSeq-VERT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2016
Registry last updated
May 28, 2024

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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