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A study on the application value of gene mutation detection in peripheral blood in clinical risk stratification for pediatric Langerhans cell histiocytosis

A study on the application value of gene mutation detection in peripheral blood in clinical risk stratification for pediatric Langerhans cell histiocytosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060335
Enrollment
Unknown
Registered
2022-05-28
Start date
2022-05-16
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Langerhans cell histiocytosis

Interventions

None listed

Sponsors

Beijing Pediatric Research Institute, Beijing Children’s Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed as LCH, the diagnostic criteria are lesion biopsy pathological examination and immunohistochemical staining CD1a positive and/or CD207 (ie Langerin) positive; 2. Under the age of 18 at the time of diagnosis; 3. Have not received any anti-tumor treatment before diagnosis; 4. BRAF-V600E/MAP2K1/BRAF other/ARAF/MAP3K10 and other pathogenicity-related MAPK and other signaling pathway gene mutations in lesion tissue or peripheral blood are positive at the time of diagnosis; 5. Obtain the consent of the guardian of the child and the child himself (over 8 years old), and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Screening for relevant gene mutations was not carried out at the time of diagnosis; 2. No peripheral blood gene mutation detection at any time point during diagnosis and treatment; 3. Those who cannot carry out standardized diagnosis and treatment according to the treatment plan of our hospital; 4. Patients who cannot comply during the trial and/or follow-up period.

Design outcomes

Primary

MeasureTime frame
Progression/relapse;

Secondary

MeasureTime frame
Death;

Countries

China

Contacts

Public ContactCui Lei

Beijing Pediatric Research Institute, Beijing Children’s Hospital, Capital Medical University

cuileilsh@163.com+86 13070118928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026