Prospective longitudinal observational study in LCH patients enrolled in LCH-12

Prospective longitudinal observational study of permanent consequences and prognosis in LCH patients enrolled in LCH-12 - JPLSG LCH-12-LTFU

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030220547

Enrollment

221

Registered

2022-12-29

Start date

2022-06-09

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

Langerhans cell histiocytosis Langerhans cell histiocytosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) LCH patients enrolled in LCH-12 2) Written consent for participation in this study has been obtained from the patient and/or a surrogate, depending on the patient's age

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Frequency of CNS-related permanent consequences (central diabetes insipidus, anterior pituitary dysfunction, neurodegenerative disease)	—

Secondary

Measure	Time frame
1. Cumulative recurrence rate, site of relapse, treatment for relapse, and efficacy of treatment for relapse 2. Incidence of patients with one or more CNS-related permanent consequences 3. Incidence of patients with one or more permanent consequences 4. Incidence of patients with one or more total non-central nervous system-related permanent consequences 5. Incidence of orthopedic-related permanent consequences 6. Incidence of hearing loss 7. Incidence of individual CNS-related permanent consequences 8. Incidence frequency of individual non-central nervous system-related permanent consequences 9. Evaluation of cognitive function and adaptive behavior 10. Patient quality of life assessment 11. Overall survival, event-free survival, recurrence-free survival 12. Permanent consequences free survival, CNS-related permanent consequences free survival, duration of non-CNS-related permanent consequences free survival 13. central diabetes insipidus free survival, anterior pituitary dysfunction free survival, neurodegenerative disease free survival	—

Measure

Time frame

1. Cumulative recurrence rate, site of relapse, treatment for relapse, and efficacy of treatment for relapse 2. Incidence of patients with one or more CNS-related permanent consequences 3. Incidence of patients with one or more permanent consequences 4. Incidence of patients with one or more total non-central nervous system-related permanent consequences 5. Incidence of orthopedic-related permanent consequences 6. Incidence of hearing loss 7. Incidence of individual CNS-related permanent consequences 8. Incidence frequency of individual non-central nervous system-related permanent consequences 9. Evaluation of cognitive function and adaptive behavior 10. Patient quality of life assessment 11. Overall survival, event-free survival, recurrence-free survival 12. Permanent consequences free survival, CNS-related permanent consequences free survival, duration of non-CNS-related permanent consequences free survival 13. central diabetes insipidus free survival, anterior pituitary dysfunction free survival, neurodegenerative disease free survival

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Contacts

Public ContactKenichi Sakamoto

Shiga University of Medical Science Hospital

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

Outcome results