Clinical and Molecular Characteristics of Histiocytic Disorders

Recruiting

• Conditions: Histiocytic Disorder
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06331377
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to collect medical and personal histories as well as a samples of blood, other body fluid and/or tumor/disease tissue for current and future research studies on histiocytic disorders.

Detailed Description

PRIMARY OBJECTIVES:

I. Define molecular signature and genomic landscape of histiocytic disorders. II. Correlate genomic findings with transcriptional abnormalities. III. Identify promising prognostic alterations and potential therapeutic targets.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo blood and tissue sample collection. Patients' medical records are also reviewed.

Study Timeline

• Study Start: 2017-07-27
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• * All patients diagnosed with histiocytic disorders and age ≥1 year

Exclusion Criteria

• * < 1 years age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients complete questionnaires and undergo blood and tissue sample collection. Patients' medical records are also reviewed.

Primary Outcome Measures

Name	Time	Method
Change in PD-L1 and T-cell Bim expression	Baseline; post-treatment (estimated up to 2 years, potentially 4 times per year)	Blood testing will be performed for soluble PD-L1 and T-cell Bim expressions before and after radiation therapy for histiocytic disease to assess change in levels and role of immunotherapy. For any test results that are actionable, patients will be notified and the results will be available in the electronic medical record.
Identify molecular markers	Baseline	Biopsy samples will be analyzed for the presence of molecular markers associated with histiocytic disorders. Potential markers include BRAF V600E, cyclinD1, PD-L1, p16, and p53.6. For any test results that are actionable, patients will be notified and the results will be available in the electronic medical record.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States