Clinical trial NCT05028621: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Castleman's Disease (CD)
Langerhans Cell Histiocytosis (LCH)
Non-Langerhans-Cell Histiocytosis
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of genomic analyses yielding genetic aberrations
timeFrame: Up to 12 months from last participant accrued
Secondary outcomes:
measure: Proportion of genomic analyses yielding actionable genetic aberrations
timeFrame: Up to 12 months from last participant accrued
measure: Proportion of genomic analyses yielding germline genetic aberrations
timeFrame: Up to 12 months from last participant accrued
measure: Referral rates for genetic counseling for germline mutations
timeFrame: Up to 12 months from last participant accrued
measure: Completion rates of genetic counseling for germline mutations
timeFrame: Up to 12 months from last participant accrued
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Sudipto Mukherjee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: