Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05915208

Conditions

Histiocytosis

Langerhans Cell Histiocytosis

Erdheim-Chester Disease

Rosai Dorfman Disease

Xanthogranuloma

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of the study is to describe the burden of chronic health conditions, psychological dysfunction, chronic pain, healthcare utilization, worse health-related quality of life, overall mortality, and cause-specific mortality among individuals with histiocytic disorders

Conditions

Histiocytosis

Langerhans Cell Histiocytosis

Erdheim-Chester Disease

Rosai Dorfman Disease

Xanthogranuloma

Study ID

NCT05915208

Start date

Sep 1, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosis of histiocytic disorder at any age

1. Langerhans cell histiocytosis,
2. Erdheim-Chester disease,
3. Rosai-Dorfman disease,
4. Xanthogranuloma,
5. Mixed histiocytosis
6. Malignant histiocytosis (Histiocytic sarcoma, langerhans cell sarcoma, interdigitating cell sarcoma)
7. Hemophagocytic lymphohistiocytosis

Exclusion Criteria:

  • None

Study Design

Enrollment

6000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Chronic health conditions diagnosed after LCH diagnosis graded using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0 (https://ctep.cancer.gov) [ Time Frame: From diagnosis of histiocytic disorder to age at completion of survey, assessed up to 200 months ]
  • All-cause and cause-specific mortality [ Time Frame: 2 years preceding death ]

Central Contacts and Locations

Central contacts

Gaurav Goyal, MD

1-866-438-1640histio@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Gaurav Goyal, MD

1-866-438-1640histio@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • survivorship
  • long-term
  • targeted therapy
  • second cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-12.