Trial Outcomes & Findings for VircapSeq Virus Detection in Sézary Syndrome (NCT NCT02836886)
NCT ID: NCT02836886
Last Updated: 2024-05-28
Results Overview
Recruitment status
COMPLETED
Target enrollment
6 participants
Primary outcome timeframe
Through study completion, an average of 4 months
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
Sézary Syndrome
Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VircapSeq Virus Detection in Sézary Syndrome
Baseline characteristics by cohort
| Measure |
Sézary Syndrome
n=6 Participants
Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
65 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 4 monthsOutcome measures
| Measure |
Sézary Syndrome
n=6 Participants
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
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 4 monthsOutcome measures
| Measure |
Sézary Syndrome
n=6 Participants
Patients diagnosed with Sézary syndrome diagnosed according to the WHO-EORTC criteria.
|
|---|---|
|
Number of Coding Sequences for Viral Pathogens Extracted From T Cells of Patients With Sézary Syndrome
|
0 coding sequences for viral pathogens
|
Adverse Events
Sézary Syndrome
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place