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NCT Number: NCT06480591

Evaluation of the Pathobiology of CALR-mutated MPN Cells

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health Levine Cancer, Charlotte, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Blood Draw

Other

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

Primary outcomes

  1. Expression levels of TLR 2 and TLR 4

    Time frame: 24 months

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

Secondary outcomes

  1. Plasma levels of inflammatory cytokines

    Time frame: 24 months

    Presence and levels of inflammatory cytokines, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be recorded by multiplex Elisa for each participant.

  2. Plasma levels of inflammatory cytokines following incorporation of TLR ligands

    Time frame: 24 months

    Presence and levels of inflammatory cytokines, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be calculated for each participant using the in vitro cell culture system.

  3. History of thrombosis

    Time frame: 24 months

    Determined for each participant as a binary variable indicating whether this participant had history of thrombosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Schepel

CONTACT

[email protected]

(980) 292-0817

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute
  • Brookdale University Hospital Medical Center

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2024
Registry last updated
Jul 13, 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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