Prospective Study of BK Virus Disease After Allogeneic Hematopoietic-cell Transplantation: Defining BK Disease's Natural History, Clinical Spectrum, Immunology, and Outcomes
1 other identifier
observational
100
1 country
1
Brief Summary
This research study is evaluating the reactivation of BK virus in patients who have undergone allogeneic hematopoietic-cell transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2018
CompletedFirst Posted
Study publicly available on registry
May 22, 2018
CompletedStudy Start
First participant enrolled
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2020
CompletedMay 22, 2024
May 1, 2024
2.1 years
May 10, 2018
May 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean total number of cytokine producing BKV-specific NK and T-cells at the time of BKVD in affected patients, as compared with unaffected patients
2 years
Secondary Outcomes (2)
Analytically determine a BKV-specific cfDNA methylation pattern in the urine and plasma samples of affected patients
2 years
Analytically determine BKV-specific antibody glycosylation patterns in plasma samples of patients who exhibit BKVR.
2 years
Study Arms (1)
allogeneic hematopoietic-cell transplantation patients
Prospective HCT cohort of patients undergoing allogeneic HCT at DFCI
Interventions
A survey administered to identify the symptoms of the patient
quantitative PCR testing
Standard questionnaires validated for HCT recipients
Eligibility Criteria
All adult patients who undergo allo-HCT will be eligible for the study, regardless of age, underlying disease, conditioning regimen, or GVHD prophylaxis regimen
You may qualify if:
- Adult ≥18 years old
- All adult patients who undergo allo-HCT will be eligible for the study, regardless of age, underlying disease, conditioning regimen, or GVHD prophylaxis regimen
You may not qualify if:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jerome Ritz, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 10, 2018
First Posted
May 22, 2018
Study Start
July 30, 2018
Primary Completion
September 14, 2020
Study Completion
September 14, 2020
Last Updated
May 22, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share