GVHD - Graft-Versus-Host Disease
Conditions
Brief summary
This is a prospective single arm study with the study period from June 1st, 2019 to May 31st, 2020. An historical control group will be used in the study, which includes all patients received HSCT but not GI panel detection between June 1st, 2018 to May 31st, 2019. All patients receiving HSCT within the year at SCMC will be enrolled in the study. The stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (T1), 28+-3 days after HSCT (T2), and the day severe diarrhea present (T3). All the stool samples will be detected by the FilmArray GI panel, and the results as well as other clinical information including the laboratory examinations will be recorded and analyzed.
Interventions
DIAGNOSTIC_TESTFilmArray Gastrointestinal (GI) Panel
The FilmArray GI Panel tests for 22 of the most commonly associated pathogens related to gastroenteritis-all from one patient sample, one easy to use reagent, and results are available in about one hour.
Sponsors
BioMérieux
Shanghai Children's Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age ≤ 18 years old; * Receiving HSCT; * Legal guardians fully understand and sign informed consent.
Exclusion criteria
* Receiving secondary transplantation; * Cannot give informed consent or not willing to enroll the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive rate of FilmArray GI test before and post-HSCT | 31 days after HSCT |
| Compare the FilmArray GI test results generated from the same patients in different time points | 31 days after HSCT |
Contacts
Primary ContactQing Cao, MD
Backup ContactYue Tao, PhD
Outcome results
None listed