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NCT03570411 · ClinicalTrials.gov registry record
Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- 11
- Enrollment target
NCT03570411: Clinical Trial study, sponsored by St. Jude Children's Research Hospital.
NCT03570411 is a clinical trial that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03570411 was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- 11 participants
- Enrollment target
Study Summary
The ability to distinguish allogeneic hematopoietic cell transplantation (allo-HCT) recipients at risk for cytomegalovirus (CMV) reactivation from those who are not is central for optimal CMV management strategies. Measuring this cell mediated immunity has been proposed as a potent tool to predict those patients at highest risk of CMV reactivation and disease. This study will evaluate the ability of the T-SPOT.CMV test to predict Cytomegalovirus (CMV) reactivation in allogeneic hematopoietic cell transplantation (allo-HCT) pediatric recipients. Primary Objectives: To evaluate feasibility of T-SPOT.CMV spot count test in allo-HCT pediatric recipients. To evaluate association of T-SPOT.CMV spot count in the first sample collected after patient has engrafted with subsequent CMV reactivation in allo-HCT pediatric recipients. Secondary Objectives: To evaluate the correlation between T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count. To explore the relationship between recipient T-SPOT.CMV spot counts and subsequent CMV infection related morbidity and treatment outcomes among pediatric all-HCT recipients.
Primary Outcome
Percentage of the first 30 participants enrolled on study reach day +90 with at least one evaluable sample will be reported.
Interventions
- DIAGNOSTIC_TEST T-SPOT®.CMV Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2019-04-22 |
Why NCT03570411 stopped before completion
NCT03570411 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which T-SPOT®.CMV Test is the first listed.
NCT03570411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03570411 about?
NCT03570411 is a clinical study titled "Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant". The ability to distinguish allogeneic hematopoietic cell transplantation (allo-HCT) recipients at risk for cytomegalovirus (CMV) reactivation from those who are not is central for optimal CMV management strategies. Measuring this cell mediated immunity has been proposed as a potent tool to predict t...
What is the current status of trial NCT03570411?
This trial is currently terminated. The enrollment target is 11 participants. The study started on 2018-07-16. Estimated completion is 2019-04-22.
What interventions are being tested in trial NCT03570411?
The interventions under investigation include: T-SPOT®.CMV Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03570411?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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