Clinical trial NCT02836886: VircapSeq Virus Detection in Sézary Syndrome
Official title: Searching for Oncogenic Viruses in Sézary Cells Using a Novel Viral Discovery Technique, VirCapSeq-VERT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, T-Cell, Cutaneous
Sézary Syndrome
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Sézary syndrome diagnosed according to the WHO-EORTC criteria.

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%.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
measure: Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome
timeFrame: Through study completion, an average of 4 months
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Larisa G Geskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mirvish JJ, Pomerantz RG, Falo LD Jr, Geskin LJ. Role of infectious agents in cutaneous T-cell lymphoma: facts and controversies. Clin Dermatol. 2013 Jul-Aug;31(4):423-431. doi: 10.1016/j.clindermatol.2013.01.009.
citation: Briese T, Kapoor A, Mishra N, Jain K, Kumar A, Jabado OJ, Lipkin WI. Virome Capture Sequencing Enables Sensitive Viral Diagnosis and Comprehensive Virome Analysis. mBio. 2015 Sep 22;6(5):e01491-15. doi: 10.1128/mBio.01491-15.
citation: Anderson ME, Nagy-Szakal D, Jain K, Patrone CC, Frattini MG, Lipkin WI, Geskin LJ. Highly Sensitive Virome Capture Sequencing Technique VirCapSeq-VERT Identifies Partial Noncoding Sequences but no Active Viral Infection in Cutaneous T-Cell Lymphoma. J Invest Dermatol. 2018 Jul;138(7):1671-1673. doi: 10.1016/j.jid.2018.01.024. Epub 2018 Feb 7. No abstract available.