Lymphoma, T-Cell, Cutaneous, Sézary Syndrome
Conditions
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%.
Interventions
None listed
Sponsors
Columbia University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Other
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sézary Syndrome Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Sézary Syndrome |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 65 years |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sézary Syndrome | Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome | 6 Participants |
Other Pre-specified
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sézary Syndrome | Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome | 0 coding sequences for viral pathogens |