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Dried Blood Spot Testing of CMV Detection in HCT Recipients
NCT03910478 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized clinical trial to assess whether a subject centered, self-collection of Dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients \> /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing.
Conditions Studied
Interventions
- DEVICE DBS Self-Collection Kit
- OTHER Standard Control Strategy
Study Locations (4)
Minnesota
- University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine — Minneapolis
New York
- Memorial Sloan Kettering Cancer Center — New York
Texas
- The University of Texas - MD Anderson Cancer Center - Infectious Diseases — Houston
Washington
- Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 622 participants |
| Start Date | 2019-05-03 |
| Est. Completion | 2024-01-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03910478
The ClinicalTrials.gov registry entry for NCT03910478 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 622 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cytomegalovirus Infection appearing as the primary indexed condition, and to 2 interventions — of which DBS Self-Collection Kit is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03910478 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Minnesota, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03910478 about?
NCT03910478 is a clinical study titled "Dried Blood Spot Testing of CMV Detection in HCT Recipients". This is a randomized clinical trial to assess whether a subject centered, self-collection of Dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk fo...
What is the current status of trial NCT03910478?
This trial is currently completed. It is a NA study. The enrollment target is 622 participants. The study started on 2019-05-03. Estimated completion is 2024-01-16.
What conditions does trial NCT03910478 study?
This clinical trial studies the following conditions: Cytomegalovirus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03910478?
The interventions under investigation include: DBS Self-Collection Kit (DEVICE), Standard Control Strategy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03910478?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03910478 being conducted?
This trial has 4 study locations across Minnesota, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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