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

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

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.

Study Overview

• Status: Unknown
• Conditions: GVHD - Graft-Versus-Host Disease
• Intervention / Treatment: Diagnostic test: FilmArray Gastrointestinal (GI) Panel

• Study Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients receiving HSCT within the year at SCMC

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai Children's Medical Center
• Collaborators: BioMérieux

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: GI-GVHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No