An observational study in Lymphoma, T-Cell, Cutaneous and Sézary Syndrome, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Columbia University · Observational
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%.
164 studies on the registry are indexed under Sezary Syndrome; 21 are open to participants now.
This study's enrollment of 6 is below the median of 120 across 19 observational studies indexed under Sezary Syndrome.
Browse Sezary Syndrome studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
Exclusion Criteria:
Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome
Time frame: Through study completion, an average of 4 months
Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome
Time frame: Through study completion, an average of 4 months
| Milestone | Sézary Syndrome |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
| Participants | Sézary Syndrome |
|---|---|
| Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome | 6 |
| coding sequences for viral pathogens | Sézary Syndrome |
|---|---|
| Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome | 0 |
Collected over Through study completion, an average of 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sézary Syndrome | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Sézary Syndrome |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 1 |
| Age, Continuous(years) | Sézary Syndrome |
|---|---|
| Mean | 65 (58 to 82) |
| Sex: Female, Male(Participants) | Sézary Syndrome |
|---|---|
| Female | 5 |
| Male | 1 |
| Region of Enrollment(participants) | Sézary Syndrome |
|---|---|
| United States | 6 |
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Columbia University