VircapSeq Virus Detection in Sézary Syndrome

NCT02836886 | Completed Results

• 1 other identifier: AAAQ9017
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, T-Cell, Cutaneous; Sézary Syndrome

Outcome Measures

Primary Outcomes (1)

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

  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

  Through study completion, an average of 4 months

Study Arms (1)

Sézary syndrome

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (8)

• Willemze R, Jaffe ES, Burg G, Cerroni L, Berti E, Swerdlow SH, Ralfkiaer E, Chimenti S, Diaz-Perez JL, Duncan LM, Grange F, Harris NL, Kempf W, Kerl H, Kurrer M, Knobler R, Pimpinelli N, Sander C, Santucci M, Sterry W, Vermeer MH, Wechsler J, Whittaker S, Meijer CJ. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005 May 15;105(10):3768-85. doi: 10.1182/blood-2004-09-3502. Epub 2005 Feb 3.

  PMID: 15692063 BACKGROUND

• Siegel RS, Pandolfino T, Guitart J, Rosen S, Kuzel TM. Primary cutaneous T-cell lymphoma: review and current concepts. J Clin Oncol. 2000 Aug;18(15):2908-25. doi: 10.1200/JCO.2000.18.15.2908.

  PMID: 10920140 BACKGROUND

• Henn A, Michel L, Fite C, Deschamps L, Ortonne N, Ingen-Housz-Oro S, Marinho E, Beylot-Barry M, Bagot M, Laroche L, Crickx B, Maubec E. Sezary syndrome without erythroderma. J Am Acad Dermatol. 2015 Jun;72(6):1003-9.e1. doi: 10.1016/j.jaad.2014.11.015.

  PMID: 25981000 BACKGROUND

• Lessin SR, Vowels BR, Rook AH. Retroviruses and cutaneous T-cell lymphoma. Dermatol Clin. 1994 Apr;12(2):243-53.

  PMID: 8045036 BACKGROUND

• Willerslev-Olsen A, Krejsgaard T, Lindahl LM, Bonefeld CM, Wasik MA, Koralov SB, Geisler C, Kilian M, Iversen L, Woetmann A, Odum N. Bacterial toxins fuel disease progression in cutaneous T-cell lymphoma. Toxins (Basel). 2013 Aug 14;5(8):1402-21. doi: 10.3390/toxins5081402.

  PMID: 23949004 BACKGROUND

• 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.

  PMID: 23806159 BACKGROUND

• 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.

  PMID: 26396248 BACKGROUND

• 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.

  PMID: 29427587 BACKGROUND

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.

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Sezary Syndrome

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Larisa Geskin, MD
• Organization: Columbia University

ljg2145@cumc.columbia.edu

2123055550

Study Officials

• Larisa G Geskin, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 19, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)