- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836886
VircapSeq Virus Detection in Sézary Syndrome
February 6, 2017 updated by: Larisa Geskin, Columbia University
Searching for Oncogenic Viruses in Sézary Cells Using a Novel Viral Discovery Technique, VirCapSeq-VERT
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Sézary syndrome
Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of viral sequences present in malignant T cells of patients with Sézary syndrome
Time Frame: Up to 1 week
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White blood cells samples will be analyzed with technique called "VirCapSeq-VERT"
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Up to 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Larisa G Geskin, MD, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: J Clin Oncol 2001 Nov 1;19(21):4185.
- 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.
- 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.
- Lessin SR, Vowels BR, Rook AH. Retroviruses and cutaneous T-cell lymphoma. Dermatol Clin. 1994 Apr;12(2):243-53.
- 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.
- 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.
- 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. Erratum In: MBio. 2017 May 16;8(3):
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
July 15, 2016
First Submitted That Met QC Criteria
July 15, 2016
First Posted (Estimate)
July 19, 2016
Study Record Updates
Last Update Posted (Estimate)
February 8, 2017
Last Update Submitted That Met QC Criteria
February 6, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAQ9017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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