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Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease

Primary Purpose

Castleman's Disease (CD), Langerhans Cell Histiocytosis (LCH), Non-Langerhans-Cell Histiocytosis

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Genetic testing

About this trial

This is an interventional screening trial for Castleman's Disease (CD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must have histopathologic confirmation of the particular rare hematologic disease.
Diseases that will be considered as rare hematologic diseases for this study will include the following
- Langerhans cell histiocytosis (LCH)
- Erdhiem Chester disease (ECD)
- Rosai-Dorfman disease (RDD)
- Miscellaneous histiocytic entities -indeterminate dendritic cell tumor, interdigitating dendritic cell sarcoma, follicular dendritic cell sarcoma, fibroblastic reticular cell tumor
- Unicentric Castleman disease
- Multicentric Castleman disease including TAFRO
- Follicular Dendritic Cell sarcoma (FDCS)
Newly diagnosed treatment naïve patients as well as patients who received prior therapies (e.g. chemotherapy, targeted therapy, surgery, or radiation) will be included. -Tissue specimens collected within the past 5 yearse will be considered acceptable for study inclusion will include the following
Collected as part of the evaluation for diagnostic confirmation
Tissue specimen or extracted DNA (from blood sample) banked in IRB approved tissue repositories and obtained within five years prior to the date of informed consent. -Tissue samples are planned to be collectedfrom previously stored surgical specimens already being stored in pathology lab
Consent to have germline testing performed in parallel to tumor testingg)Patients willing to receive treatmen

Exclusion Criteria:

Life expectancy of less than 6months
Patient unwilling to have germline testing performed on peripheral blood or buccal mucosa

Sites / Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genomic analysis

Arm Description

When a participant's disorder was diagnosed, blood or tissue specimen was collected. A part of the tissue or blood will be sent to an outside company, Tempus, to be tested for specific genetic changes and the results will be sent back to participants' physician.

Outcomes

Primary Outcome Measures

Proportion of genomic analyses yielding genetic aberrations

Proportion of genomic analyses yielding actionable genetic aberrations. "Actionable" is defined as a mutation linked to an approved therapy in the particular disease under study or another disease, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration

Secondary Outcome Measures

Proportion of genomic analyses yielding actionable genetic aberrations

Actionable will be defined as a mutation linked to an approved therapy in the particular disease or another disease, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration.

Proportion of genomic analyses yielding germline genetic aberrations

Referral rates for genetic counseling for germline mutations

Number of participants with germline mutations who were referred to genetic counseling through Cancer Genetics for their identified germline mutations

Completion rates of genetic counseling for germline mutations

Number of participants with germline mutations who were referred to, and underwent (completed) genetic counseling through Cancer Genetics.

Full Information

NCT ID

NCT05028621

First Posted

August 25, 2021

Last Updated

March 20, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05028621

Brief Title

Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease

Official Title

Exploratory Analysis of the Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Suspended

Why Stopped

Working on changing study vendor

Study Start Date

June 18, 2021 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to use agnostic genomic evaluation using whole exome sequencing (WES) of a variety of rare hematologic diseases grouped under rare blood diseases and its variants to further elucidate the understanding of the chemistry of these disorders and identify potential actionable mutations that can be targeted with therapies in the context of clinical trials.

Detailed Description

The study team will examine genetic changes, also known as mutations, in the DNA of participants' blood, or if applicable, bone marrow specimen. These types of tests are increasingly used by doctors to improve the accuracy of diagnosis and make decisions during care. This study seeks to understand how many patients will benefit from this testing, and in what ways. The results of this portion of the study are placed in the individual's medical record and are communicated back to each participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Castleman's Disease (CD), Langerhans Cell Histiocytosis (LCH), Non-Langerhans-Cell Histiocytosis

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Genomic analysis

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Genetic testing

Intervention Description

Genetic testing of blood or tissue sample and limited medical information sent to an outside company. Database will link genome sequence data with human trait information, including cancer and other diseases, to be sent to participant's physician.

Primary Outcome Measure Information:

Title

Proportion of genomic analyses yielding genetic aberrations

Description

Time Frame