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Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant

NCT03570411 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2019-06-11

No results posted yet for this 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.

Conditions

  • CMV

Interventions

DIAGNOSTIC_TEST

T-SPOT®.CMV Test

The T-SPOT.CMV test (Oxford Diagnostic Laboratories) measures the strength of T cell responses to CMV specific antigens. Using whole blood samples obtained through a standard blood collection tube, white blood cells (WBC's) are separated and purified. The cells are quantified and placed into specially designed plates where they are challenged with antigens specific to the disease under study. Disease-specific cells responding to these antigens will release immune messenger molecules, called cytokines. We then use chemistry to allow us to visualize those WBCs releasing cytokines (and hence those which react to the antigen), resulting in a spot on the bottom of the plate, corresponding to the footprint of an individual reacting WBC. Finally, we use an automated image analysis system to identify and count each of these spots to give a quantitative readout. That quantitative readout gives us the frequency of responsive disease-specific cells (Oxford Immunotec, 2017).

Sponsors & Collaborators

Principal Investigators

  • Diego Hijano, MD · St. Jude Children's Research Hospital

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-04-22
Completion
2019-04-22

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570411 on ClinicalTrials.gov