VircapSeq Virus Detection in Sézary Syndrome

Completed

• Conditions: Sézary Syndrome; Lymphoma, T-Cell, Cutaneous

• Registration Number: NCT02836886
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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%.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-19
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2021-08-13
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Results First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome	Through study completion, an average of 4 months

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States