NCT06247891

Brief Summary

The goal of this clinical trial is to test the assess the diagnostic effectiveness of endocytoscopy in patients with underlying UGI aGvHD. The main question it aims to answer is: the effectiveness of ECS for diagnosing UGI aGvHD. Participants will undergo endoscopy, endocytoscopic evaluation and biopsy simultaneously. If there is a comparison group: Researchers will compare endoscopic, endocytoscopic and pathologic findings of these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

January 8, 2024

Last Update Submit

January 30, 2024

Conditions

Endocytoscopy

Keywords

Endocytoscopyacute graft-versus-host disease

Outcome Measures

Primary Outcomes (1)

  • the effectiveness of endocytoscopy for diagnosing UGI aGvHD

    the percentage of esophageal, gastric, and duodenal UGI aGvHD diagnosed by endocytoscopy

    three months

Study Arms (1)

Control Group

OTHER
Procedure: ECS Group

Interventions

ECS GroupPROCEDURE

Patients underwent endoscopic and endocytoscopic evaluations.

Control Group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • aged ≥ 14 years
  • developed UGI symptoms within first three months after engraftment or during the tapering of immunosuppressive agents

You may not qualify if:

  • \< 14 year
  • with underlying gastrointestinal disease before allo-HSCT
  • incomplete medical information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ye Zhao

Shanghai, 210000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

February 8, 2024

Study Start

August 1, 2021

Primary Completion

August 30, 2023

Study Completion

November 30, 2023

Last Updated

February 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

CN(1)