Prospective observational study for histiocytosis in Japan

Prospective observational study for histiocytosis in Japan - JPLSG LCH-19-Histio

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030220548

Enrollment

150

Registered

2022-12-29

Start date

2022-05-23

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

Histiocytosis Histiocytosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically diagnosed (including suspected) as histiocytosis (LCH or non-LCH) at the institution. (2) Able to submit samples to a central pathology laboratory. (3) Fully informed and consent must be obtained in writing.

Exclusion criteria

Exclusion criteria: (1) Cases enrolled Phase II clinical trial (LCH-19-MSMFB) (2) Cases diagnosed with hemophagocytic lymphohistiocytosis (HLH)

Design outcomes

Primary

Measure	Time frame
Clinical characteristics of newly diagnosed histiocytosis during the study period by disease and type at onset	—

Secondary

Measure	Time frame
1) Agreement rate between institutional pathology diagnosis and central pathology diagnosis 2) Initial treatment efficacy 3) Overall survival, event-free survival, and progression-free survival 4) Cumulative relapse rate 5) Cumulative incidence of CNS-related permanent consequences and Non-CNS-related permanent consequences 6) Progression of patients with single system single site LCH in pediatric patients who were selected for observation	—

Measure

Time frame

1) Agreement rate between institutional pathology diagnosis and central pathology diagnosis 2) Initial treatment efficacy 3) Overall survival, event-free survival, and progression-free survival 4) Cumulative relapse rate 5) Cumulative incidence of CNS-related permanent consequences and Non-CNS-related permanent consequences 6) Progression of patients with single system single site LCH in pediatric patients who were selected for observation

—

Contacts

Public ContactKenichi Sakamoto

Shiga University of Medical Science Hospital

sken1@belle.shiga-med.ac.jp+81-77-548-2228

Outcome results