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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| LCI-HEM-MPN-CALR-001 | Other Identifier | Atrium Health |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
| Brookdale University Hospital Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAK2 V617F mutation positive MPN patients | Patients with MPN disease with a JAK2 mutation |
| |
| CALR-mutation positive patients | Patients with MPN disease with a CALR mutation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Other | The amount of blood that will be collected for this is 50 mL(milliliters), or about 3 ½ tablespoons. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expression levels of TLR 2 and TLR 4 | Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Plasma levels of inflammatory cytokines following incorporation of TLR ligands |
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Inclusion Criteria:
Exclusion Criteria:
- Diagnosis of MPN with JAK2 V617F mutation
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Patients seen in the clinic with MPN with the CALR mutation will be identified and approached for consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Schepel | Contact | (980) 292-0817 | Courtney.Schepel@atriumhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Aleksander Chojecki, MD | Atrium Health Levine Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Levine Cancer | Recruiting | Charlotte | North Carolina | 28204 | United States |
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
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| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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. |
| 24 months |
| History of thrombosis | Determined for each participant as a binary variable indicating whether this participant had history of thrombosis. | 24 months |
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |