NCT06331377

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2017Jul 2027

Study Start

First participant enrolled

July 27, 2017

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

March 18, 2024

Last Update Submit

September 3, 2025

Conditions

Histiocytic Disorder

Outcome Measures

Primary Outcomes (2)

  • Identify molecular markers

    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

    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)

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with histiocytic disorders

You may qualify if:

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

You may not qualify if:

  • \* \< 1 years age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Study Officials

  • Ronald S. Go, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 26, 2024

Study Start

July 27, 2017

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations

US(1)