ClinicalTrials.gov record NCT05915208

Histiocytic Disorder Follow-up Study

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Histiocytic Disorder Follow-up Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
AgeUnder 1 month old to 89 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This retrospective observational study describes long-term health burdens in people diagnosed with histiocytic disorders, including children and people. Participants' medical records and a validated questionnaire will be used to capture chronic health conditions, quality of life, cognitive/psychological function, healthcare use, and causes of death. The study aims to measure how common these problems are and to inform future follow-up care.

What it is studying. The study aims to describe the burden of chronic medical conditions, psychological or cognitive dysfunction, chronic pain, healthcare use, health-related quality of life, overall mortality, and cause-specific mortality among people with histiocytic disorders. It will also explore factors associated with new-onset morbidity and build prediction models for outcomes such as second primary cancers and psychological problems.

What the researchers hope to learn. To measure how often and how severe long-term health problems and causes of death occur after a diagnosis of a histiocytic disorder; to identify factors linked to new long-term health problems; and to provide data that could help develop follow-up guidelines and survivorship programs.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • diagnosis of histiocytic disorder at any age
  • Langerhans cell histiocytosis,
  • Erdheim-Chester disease,
  • Rosai-Dorfman disease,
  • Xanthogranuloma,
  • Mixed histiocytosis
  • Malignant histiocytosis (Histiocytic sarcoma, langerhans cell sarcoma, interdigitating cell sarcoma)
  • Hemophagocytic lymphohistiocytosis

Exclusion criteria

  • None

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Background Over the last decade, major advances have occurred in histiocytic disorders with the discovery of MAPK-ERK pathway mutations leading to targeted therapeutics using BRAF- and MEK-inhibitors. However, there is a lack of large studies informing the burden of morbidity and mortality among people with histiocytosis. Institutional studies in pediatric LCH suggest that survivors suffer from long-term impairment of health related quality of life, cognitive dysfunction, pituitary dysfunction, and hearing difficulties in 20-50% cases. Studies from the investigative team and others have also shown a high incidence of acute myeloid leukemia and other second primary malignancies in pediatric and adult LCH. Chronic medical conditions may arise as a function of the disease biology or due to cancer therapy, as seen in other hematologic malignancies. Design Retrospective cohort study aimed at determining the risk of chronic health conditions and cause-specific mortality in pediatric and adult patients with histiocytic disorders. The study will include patients from the Histiocytosis Association registry and other institutions including UAB (n~6000). The participants will complete a validated questionnaire capturing details of chronic health conditions, health related quality of life, cognitive/psychological function, and healthcare utilization. Future directions The results from our study will be instrumental in formulating follow-up guidelines for histiocytic disorders and developing targeted survivorship programs to improve overall outcomes.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Most participants will complete a validated questionnaire about chronic health conditions, health‑related quality of life, cognitive and psychological function, and healthcare use. The study will use existing registry and participating‑center data (for example from the Histiocytosis Association registry and institutional records). Next‑of‑kin of deceased patients may be asked to provide information. The record does not list any invasive tests or procedures for participants.

How the study is structured. A retrospective cohort observational study using data from the Histiocytosis Association registry and participating institutions. Investigators will review past medical records and invite participants to complete a validated questionnaire about health conditions, quality of life, cognitive and psychological function, and healthcare use. Analyses will compare rates of serious chronic conditions and causes of death over time (assessed up to about 200 months from diagnosis).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Erdheim-Chester disease

This trial is also listed on this site under Langerhans cell histiocytosis.

Clinical trials11 trials listed for Erdheim-Chester diseaseEvery trial the registry lists for Erdheim-Chester disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Erdheim-Chester disease researchLatest monthly update: September 2026. Includes: BRAF-targeted treatment. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 1, 2022
Primary completion
July 2027 (estimated)
Study completion
December 2028 (estimated)
Target enrollment
6000 participants (estimated)
Last updated on registry
Jun 12, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Alabama at Birmingham
Principal investigator
Gaurav Goyal, Principal Investigator
University of Alabama at Birmingham

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Retrospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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