Myeloproliferative Neoplasm
Conditions
Keywords
Thrombosis, JAK2 mutation, CALR mutation
Brief 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.
Interventions
OTHERBlood Draw
The amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons.
Sponsors
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute
Brookdale University Hospital Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expression levels of TLR 2 and TLR 4 | 24 months | Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma levels of inflammatory cytokines | 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. |
| Plasma levels of inflammatory cytokines following incorporation of TLR ligands | 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. |
| History of thrombosis | 24 months | Determined for each participant as a binary variable indicating whether this participant had history of thrombosis. |
Countries
United States
Contacts
CONTACTCourtney Schepel
PRINCIPAL_INVESTIGATORAleksander Chojecki, MD
Atrium Health Levine Cancer
Outcome results
None listed