Clinical and Molecular Characteristics of Histiocytic Disorders

September 3, 2025 updated by: Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Ronald S. Go, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with histiocytic disorders

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • * < 1 years age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients complete questionnaires and undergo blood and tissue sample collection. Patients' medical records are also reviewed.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify molecular markers
Time Frame: 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.
Baseline
Change in PD-L1 and T-cell Bim expression
Time Frame: 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.
Baseline; post-treatment (estimated up to 2 years, potentially 4 times per year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ronald S. Go, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2017

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 17-004541 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2024-01765 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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