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NCT Number: NCT05028621

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

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.

Why the study stopped: Working on changing study vendor
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Key information

Conditions

Castleman's Disease (CD) Castleman Disease Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Langerhans-Cell Histiocytosis, Non-Langerhans-Cell Immune System Diseases Immunoproliferative Disorders Langerhans Cell Histiocytosis (LCH) Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Non-Langerhans-Cell Histiocytosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic testing

Diagnostic Test

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 outcomes

  1. Proportion of genomic analyses yielding genetic aberrations

    Time frame: Up to 12 months from last participant accrued

    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 outcomes

  1. Proportion of genomic analyses yielding actionable genetic aberrations

    Time frame: Up to 12 months from last participant accrued

    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.

  2. Proportion of genomic analyses yielding germline genetic aberrations

    Time frame: Up to 12 months from last participant accrued

  3. Referral rates for genetic counseling for germline mutations

    Time frame: Up to 12 months from last participant accrued

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

  4. Completion rates of genetic counseling for germline mutations

    Time frame: Up to 12 months from last participant accrued

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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2021
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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