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RecruitingObservational

Evaluation of the Pathobiology of CALR-mutated MPN Cells

NCT ID: NCT06480591Sponsor: Wake Forest University Health SciencesLast updated: 2026-05-22

Summary

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.

Detailed 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.

Arms & interventions

  • OtherBlood Draw

    The amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons.

Outcome measures

Primary

  • Expression levels of TLR 2 and TLR 4

    Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant.

    Time frame: 24 months

Secondary

  • Plasma levels of inflammatory cytokines

    Time frame: 24 months

  • Plasma levels of inflammatory cytokines following incorporation of TLR ligands

    Time frame: 24 months

  • History of thrombosis

    Time frame: 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
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

Study locations (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204

Recruiting
Aleksander Chojecki, MD · Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

Recruiting
Ruben Mesa, MD · Principal Investigator
Evaluation of the Pathobiology of CALR-mutated MPN Cells | Cancerify