Status:
ACTIVE_NOT_RECRUITING
Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis (LCH)
Lead Sponsor:
Children's Oncology Group
Conditions:
Histiocytosis, Langerhans-Cell
Eligibility:
All Genders
Up to 25 years
Brief Summary
The long-term goal is to define the mechanisms of pathogenesis underlying Langerhans cell histiocytosis (LCH). The overall objectives of the current study are to characterize the role of SMAD6 inherit...
Detailed Description
PRIMARY OBJECTIVES: I. To comprehensively characterize germline variants in SMAD6 and their association with LCH. II. To identify novel germline variants associated with LCH. III.To determine the r...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- ≤ 25 years old at the time of original LCH diagnosis
- The patient must be enrolled on ACCRN07 and/or APEC14B1 and registered with COG by a North American member institution
- The patient must have a diagnosis of LCH (ICD Codes/Morphology: 9751/1; 9752/1; 9753/1; or 9754/3).
- The patient must be diagnosed with LCH on or after January 1, 2008.
- All questionnaire respondents must understand English or Spanish.
- All patients and/or their parents or legal guardians must provide informed consent.
- All institutional, FDA, and NCI requirements for human studies must be met.
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
647 Patients enrolled
Trial Details
Trial ID
NCT04100408
Start Date
June 1 2020
End Date
September 30 2026
Last Update
January 9 2026
Active Locations (1)
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1
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030