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NCT03910478 · ClinicalTrials.gov registry record · NA
Dried Blood Spot Testing of CMV Detection in HCT Recipients
A NA study of Cytomegalovirus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 622
- Enrollment target
- 4
- Study locations
NCT03910478: Completed NA study of Cytomegalovirus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03910478 is a NA study of Cytomegalovirus Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 622 participants, above the 120-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (418% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03910478, a NA study of Cytomegalovirus Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 622 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed \>90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.
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 |
What the finished NCT03910478 record still lists
NCT03910478 is an interventional study that assigns participants to a tested intervention. The registered 622 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (418% higher).
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.
NCT03910478 reports a single indexed study location in Minnesota, New York, Texas.
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.
What interventions are being tested in trial NCT03910478?
The interventions under investigation include: DBS Self-Collection Kit (DEVICE), Standard Control Strategy (OTHER).
Who is sponsoring clinical trial NCT03910478?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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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