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Evaluation of the Pathobiology of CALR-mutated MPN Cells

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Not yet enrolling

Conditions

Myeloproliferative Neoplasm

Treatments

Other: Blood Draw

Study type

Observational

Funder types

Other

Identifiers

NCT06480591
LCI-HEM-MPN-CALR-001 (Other Identifier)
IRB00100615

Details and patient eligibility

About

The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.

Full description

This biospecimen study is designed to evaluate the expression levels of TLR 2 and TLR 4 on mononuclear cells in CALR mutation positive MPN participants and compare to JAK2 V617F mutation positive MPN patients and healthy controls. Patients who have MPN with the CALR mutation positive will be approached for interest in participating in this study. A research blood collection will occur at any time during the participant's cancer trajectory after enrollment, during a standard of care blood draw. The participant's demographics, MPN subtype, CALR mutation status, history of thrombosis/other medical history, and current, concomitant medications will be collected once. Clinical data will be collected, including results from the CBC with differential, complete metabolic panel (if available), and PT/PTT/INR (if available) drawn closest to the research blood collection. This study will initially open as a single center study at AHWFBCCC.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Written (or electronic) informed consent and HIPAA authorization for release of personal health information by participant or his/her legally authorized representative (LAR).
  • Age ≥ 18 years at the time of enrollment
  • Diagnosis of myeloproliferative neoplasm (MPN) according to 2022 World Health Organization classification of MDS/MPNs
  • CALR-positive genetic mutation

Exclusion criteria

  • Diagnosis of MPN with JAK2 V617F mutation

Trial design

35 participants in 2 patient groups

JAK2 V617F mutation positive MPN patients
Description:
Patients with MPN disease with a JAK2 mutation
Treatment:
Other: Blood Draw
CALR-mutation positive patients
Description:
Patients with MPN disease with a CALR mutation
Treatment:
Other: Blood Draw

Trial contacts and locations

2

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Central trial contact

Courtney Schepel

Data sourced from clinicaltrials.gov

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