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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

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I had a stem cell transplant from a donor within the last year.

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I needed treatment for a CMV infection within 100 days after my transplant.

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I had a stem cell transplant from a donor between 2 to 6 months ago.

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I am 15 years old or older.

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My donor is a partial match for my transplant.

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I am using umbilical cord blood for stem cell treatment and haven't needed high-dose steroids for GVHD in the last 6 weeks.

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I have undergone T-cell depletion therapy, possibly for GVHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at one year after hematopoietic cell transplantation (hct)

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,480,510 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial restricted to individuals younger than sixty years old?

"The minimum age limit for this study is 15 and the maximum is 99."

Answered by AI

What criteria must be met to qualify for participation in this clinical investigation?

"This medical trial requires 150 participants, aged between 15 and 99 years old, who are currently living with a cytomegalovirus infection. Additional criteria includes having received an allogeneic hematopoietic cell transplant within the past 6 to 12 months; being CMV seropositive or having had a donor that was CMV positive and receiving antiviral treatment for their CMV event occurring in first 100 days post-transplant; access to the internet either through computer or smartphone device; HLA mismatch*, umbilical cord blood source**, Graft versus host disease (GVHD)***. Additionally, it is"

Answered by AI

How many people are being admitted to participate in the experiment?

"To facilitate this research project, 150 individuals that meet the set criteria must participate. Research sites in both Seattle and New york are available for potential volunteers. Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases has a presence in Washington while Memorial Sloan Kettering Cancer Center can be found in New York City."

Answered by AI

Are new participants currently being accepted for this research trial?

"Affirmative. The information on clinicaltrials.gov affirms that this medical trial is recruiting candidates; the investigation was initially posted on May 3rd 2019 and has been recently refreshed on December 1st 2022. 150 volunteers are required to be enrolled between 4 different sites."

Answered by AI

Is this clinical study accessible in any North American medical facilities?

"Currently, four locations are enrolling participants for this medical trial. These sites include Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases in Seattle, Memorial Sloan Kettering Cancer Center in New york, University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine in Minneapolis as well as a quartet of additional research centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dried Blood Spot Testing of CMV Detection in HCT Recipients

2019. "Dried Blood Spot Testing of CMV Detection in HCT Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03910478.

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