← Back to Search

Dried Blood Spot Testing for Cytomegalovirus Detection in Transplant Recipients

N/A
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have received allogeneic hematopoietic cell transplantation within 360 days prior to enrollment
CMV event* within the first 100 days post-transplant requiring anti-viral treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by 1 year after hematopoietic cell transplantation (hct)
Awards & highlights

Study Summary

This trial will assess whether self-collection of dried blood spots will improve compliance with weekly CMV testing for hematopoietic cell transplantation recipients who are at high risk for late CMV disease.

Who is the study for?
This trial is for allogeneic hematopoietic cell transplantation (HCT) recipients, aged 15 or older, who are at high risk for late Cytomegalovirus (CMV) disease. Participants must have internet access and be able to self-collect blood samples using a kit. They should not have had a CMV event within the first 100 days post-transplant that required anti-viral treatment.Check my eligibility
What is being tested?
The study tests if self-collection of dried blood spots (DBS) at home improves adherence to weekly CMV testing compared to standard clinic visits. It involves reminders via mobile devices and randomizes participants into two groups: one uses the DBS kit and the other follows usual care.See study design
What are the potential side effects?
There may not be direct side effects from participating in this trial as it involves monitoring rather than medication intervention. However, discomfort from finger-stick blood collection could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stem cell transplant from a donor within the last year.
Select...
I needed treatment for a CMV infection within 100 days after my transplant.
Select...
I had a stem cell transplant from a donor between 2 to 6 months ago.
Select...
I am 15 years old or older.
Select...
My donor is a partial match for my transplant.
Select...
I am using umbilical cord blood for stem cell treatment and haven't needed high-dose steroids for GVHD in the last 6 weeks.
Select...
I have undergone T-cell depletion therapy, possibly for GVHD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at one year after hematopoietic cell transplantation (hct)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at one year after hematopoietic cell transplantation (hct) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of participants who have completed >90% of their recommended Cytomegalovirus (CMV) monitoring tests in the DBS and control arms
Secondary outcome measures
Number of subjects in DBS and standard of care arms with end-organ Cytomegalovirus (CMV) disease, possible and proven/probable
Number of subjects with finger-stick procedure-related Grade 3 AEs
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per subject

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Self-collected Dried Blood Spot (DBS) monitoringExperimental Treatment1 Intervention
N=100 Subject collected DBS CMV monitoring with mobile technology support
Group II: Standard Monitoring ControlActive Control1 Intervention
N=50 Standard care with office based testing

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,278 Previous Clinical Trials
5,487,085 Total Patients Enrolled

Media Library

DBS Self-Collection Kit Clinical Trial Eligibility Overview. Trial Name: NCT03910478 — N/A
Cytomegalovirus Research Study Groups: Self-collected Dried Blood Spot (DBS) monitoring, Standard Monitoring Control
Cytomegalovirus Clinical Trial 2023: DBS Self-Collection Kit Highlights & Side Effects. Trial Name: NCT03910478 — N/A
DBS Self-Collection Kit 2023 Treatment Timeline for Medical Study. Trial Name: NCT03910478 — N/A
~102 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top