Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
NCT ID: NCT03570411
Last Updated: 2019-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
11 participants
OBSERVATIONAL
2018-07-16
2019-04-22
Brief Summary
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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.
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Detailed Description
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A blood sample for the T-SPOT.CMV blood test will be collected from the HCT donor prior to transplant.
Blood specimens will be collected for the T-SPOT.CMV blood test from HCT recipients over the course of 6 months, starting weekly at Day +1, biweekly starting at Day +45, and monthly starting at day +120.
HCT recipient participant demographic and clinical characteristics will be collected at enrollment. Additional clinical information will be abstracted from the HCT recipient participants medical record during the study follow-up period. This will include information related to transplant history and outcome, infections, antimicrobial exposure, chemotherapy, and laboratory values related to infectious diseases and immunosuppression.
The feasibility of the T-SPOT.CMV spot count test will be evaluated once the first 30 participants enrolled on study reach day +90. If 75% of patients have at least 1 evaluable samples after engraftment (\> 75,000 per microtiter wells), we will proceed with enrollment. If more \>25% of patients have all their samples deemed not evaluable due to insufficient mononuclear cell count (\<75,000 per microtiter wells) the study will be stopped and concluded as not feasible.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HCT Recipient
All participants who meet eligibility criteria and consent to enrollment on study.
Blood specimens will be collected for the T-SPOT.CMV blood test from HCT recipients over the course of 6 months, starting weekly at Day +1, biweekly starting at Day +45, and monthly starting at day +120.
The amount of blood collected at each visit will be based on age.
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).
HCT Donor
Approved allogeneic HCT donor for a HCT recipient enrolled on the SPOTCMV protocol
A blood sample for the T-SPOT.CMV blood test will be collected from the HCT donor prior to transplant
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Scheduled to receive allogeneic HCT at St Jude Children's Research Hospital
* HCT recipient has a documented seropositive CMV result prior to enrollment OR The HCT recipient is seronegative, but the HCT donor has a seropositive CMV result as documented in the recipient's medical record.
• Approved allogeneic HCT donor for a HCT recipient enrolled on the SPOTCMV protocol
Exclusion Criteria
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
ALL
Yes
Sponsors
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Oxford Immunotec
INDUSTRY
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Diego Hijano, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2018-01349
Identifier Type: REGISTRY
Identifier Source: secondary_id
SPOTCMV
Identifier Type: -
Identifier Source: org_study_id
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