Evaluation of the Pathobiology of CALR-mutated MPN Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Draw.
- Who it may be relevant to
- Registry conditions: Myeloproliferative Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Blood Draw
The amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons.
Primary outcome measures
- Expression levels of TLR 2 and TLR 4 [Time frame: 24 months]
Secondary outcome measures (3)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Atrium Health Levine Cancer — Charlotte
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Identifiers
NCT: NCT06480591 · IRB00100615 · P30CA012197 · LCI-HEM-MPN-CALR-001