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Evaluation of the Pathobiology of CALR-mutated MPN Cells

ConditionMyeloproliferative Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients seen in the clinic with MPN with the CALR mutation will be identified and approached for consent.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood Draw

    Other intervention

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

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: JAK2 V617F mutation positive MPN patients1 intervention
Group B: CALR-mutation positive patients1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Plasma levels of inflammatory cytokines

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.

Time frame
24 months
2

Plasma levels of inflammatory cytokines following incorporation of TLR ligands

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.

Time frame
24 months
3

History of thrombosis

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

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator

Brookdale University Hospital Medical Center

Collaborator

Source ClinicalTrials.gov
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