An observational study in Myeloproliferative Neoplasm, sponsored by Wake Forest University Health Sciences. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Wake Forest University Health Sciences · Observational
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.
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.
667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.
This study's planned enrollment of 35 is below the median of 150 across 115 observational studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients seen in the clinic with MPN with the CALR mutation will be identified and approached for consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Diagnosis of MPN with JAK2 V617F mutation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with MPN disease with a JAK2 mutation
Other: Blood Draw
Patients with MPN disease with a CALR mutation
Other: Blood Draw
The amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons.
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
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
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
History of thrombosis
Determined for each participant as a binary variable indicating whether this participant had history of thrombosis.
Time frame: 24 months
Plan to share: No — Releasing the Individual Participant Data (IPD) is not required to meet the study objectives, and therefore is not planned to be released. Additionally, there is no plan to share data, particularly individual participant data, with anyone who is not already involved in the study
No publications or documents are linked to this record.
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