Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis (LCH)

Running, not enrolling

Conditions studied: Histiocytosis, Langerhans-Cell

In brief

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 inherited genetic variation on LCH susceptibility and identify germline genomic regions associated with LCH somatic mutations. Building from preliminary data, the central hypotheses are: (1) causal genetic variants in SMAD6 underlie susceptibility to LCH, and (2) differences in LCH-related somatic activating mutations by race/ethnicity are related to Amerindian (i.e., Native American) genetic ancestry. The Central hypothesis will be tested by pursuing the specific aims.

Key facts

Study ID

NCT04100408

Run by

Children's Oncology Group

People needed

647

Starts

2020-06-01

Expected to finish

2026-09-30

Last updated by the study team

2026-01-09

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≤ 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.

Where it is running

• Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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