VircapSeq Virus Detection in Sézary Syndrome

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT02836886
Collaborator
(none)
6
1
4
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    6 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Searching for Oncogenic Viruses in Sézary Cells Using a Novel Viral Discovery Technique, VirCapSeq-VERT
    Study Start Date :
    Jun 1, 2016
    Actual Primary Completion Date :
    Oct 1, 2016
    Actual Study Completion Date :
    Oct 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Sézary syndrome

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

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of viral sequences present in malignant T cells of patients with Sézary syndrome [Up to 1 week]

      White blood cells samples will be analyzed with technique called "VirCapSeq-VERT"

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Larisa G Geskin, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Larisa Geskin, Associate Professor of Dermatology in Medicine at the Columbia U, Department of Dermatology, Columbia University
    ClinicalTrials.gov Identifier:
    NCT02836886
    Other Study ID Numbers:
    • AAAQ9017
    First Posted:
    Jul 19, 2016
    Last Update Posted:
    Feb 8, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2017