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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sézary syndrome | Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome | Through study completion, an average of 4 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome | Through study completion, an average of 4 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Larisa G Geskin, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15692063 | Background | 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. | |
| 10920140 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sézary Syndrome | Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sézary Syndrome | Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome | Posted | Count of Participants | Participants | Through study completion, an average of 4 months |
|
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Through study completion, an average of 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sézary Syndrome | Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larisa Geskin, MD | Columbia University | 2123055550 | ljg2145@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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Blood sample: two tubes collected by standard blood draw (venipuncture) procedure. The total amount of blood drawn will be about two teaspoons.
| 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. |
| 25981000 | 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. |
| 8045036 | Background | Lessin SR, Vowels BR, Rook AH. Retroviruses and cutaneous T-cell lymphoma. Dermatol Clin. 1994 Apr;12(2):243-53. |
| 23949004 | 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. |
| 23806159 | 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. |
| 26396248 | 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. |
| 29427587 | 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. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Other Pre-specified | Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome | Posted | Number | coding sequences for viral pathogens | Through study completion, an average of 4 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |