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VircapSeq Virus Detection in Sézary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836886
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Larisa Geskin, 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.

Condition or disease
Lymphoma, T-Cell, Cutaneous Sézary Syndrome

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%.

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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 : June 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Prevalence of viral sequences present in malignant T cells of patients with Sézary syndrome [ Time Frame: Up to 1 week ]
    White blood cells samples will be analyzed with technique called "VirCapSeq-VERT"


Biospecimen Retention:   Samples With DNA
Blood sample: two tubes collected by standard blood draw (venipuncture) procedure. The total amount of blood drawn will be about two teaspoons.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836886


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Larisa G Geskin, MD Columbia University
Publications:

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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: July 19, 2016    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Syndrome
Disease
Pathologic Processes
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases