Study on the Diagnostic Utility of the CD56/CD3 Ratio in Gastrointestinal Mucosal Lymphocytes for GVHD after Hematopoietic Stem Cell Transplantation

Study on the Diagnostic Utility of the CD56/CD3 Ratio in Gastrointestinal Mucosal Lymphocytes for GVHD after Hematopoietic Stem Cell Transplantation - GRAIL (GVHD Recognition by Analysis of Intraepithelial Lymphocytes using the CD56/CD3 Ratio)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059954

Enrollment

100

Registered

2025-12-03

Start date

2025-12-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients after hematopoietic stem cell transplantation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have undergone hematopoietic stem cell transplantation and are scheduled to undergo gastrointestinal endoscopy with biopsy

Exclusion criteria

Exclusion criteria: Women who are pregnant or may be pregnant

Design outcomes

Primary

Measure	Time frame
Biopsy specimens will be prospectively obtained from the gastrointestinal mucosa of patients after hematopoietic stem cell transplantation, and the CD56/CD3 ratio will be evaluated by flow cytometric analysis. The diagnostic concordance with graft-versus-host disease will be assessed by comparing the flow cytometry findings with histopathological results.	—

Countries

Japan

Contacts

Public ContactMasaya Iwamuro

Okayama University Hospital Department of Gastroenterology

iwamuromasaya@yahoo.co.jp0862357219

Outcome results