Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT Diarrhea Patients

GVHD - Graft-Versus-Host Disease Clinical Trial

Official title:

Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03894488
• Other study ID #: GI-GVHD
• Status: Not yet recruiting
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Shanghai Children's Medical Center
• Contact: Qing Cao, MD
• Phone: +86 18930830511
• Email: caoqing[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• GVHD - Graft-Versus-Host Disease

Intervention

Diagnostic Test:
• FilmArray 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center	BioMérieux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate of FilmArray GI test before and post-HSCT		31 days after HSCT
Primary	Compare the FilmArray GI test results generated from the same patients in different time points		31 days after HSCT