Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
24 participants
OBSERVATIONAL
2025-12-16
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Blood Draw Group
Participants who elect to provide specimen via standard blood draw. Some participants may provide a specimen via blood draw one time (the "blood draw group") and then elect to provide a second optional specimen via apheresis (the "apheresis group") or vice versa. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit.
Blood Draw
Participants have a standard blood draw or apheresis on study. Some participants may provide a specimen via apheresis one time (the "blood draw group") and then elect to provide a second optional specimen via a standard blood draw (the "apheresis draw group") or vice versa.
Apheresis
Participants have a standard blood draw or apheresis on study. Apheresis is a procedure where blood is drawn from your body, specific components like plasma, platelets, and/or white blood cells are separated out, and the rest of the blood is returned. Some participants may provide a specimen via apheresis one time (the "apheresis group") and then elect to provide a second optional specimen via a standard blood draw (the "blood draw group") or vice versa.
Apheresis Group
Participants who elect to provide specimen via apheresis. Apheresis is a procedure where blood is drawn from the body, specific components like plasma, platelets, and/or white blood cells are separated out, and the rest of the blood is returned. Some participants may provide a specimen via apheresis one time (the "apheresis group") and then elect to provide a second optional specimen via a standard blood draw (the "blood draw group") or vice versa. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit.
Blood Draw
Participants have a standard blood draw or apheresis on study. Some participants may provide a specimen via apheresis one time (the "blood draw group") and then elect to provide a second optional specimen via a standard blood draw (the "apheresis draw group") or vice versa.
Apheresis
Participants have a standard blood draw or apheresis on study. Apheresis is a procedure where blood is drawn from your body, specific components like plasma, platelets, and/or white blood cells are separated out, and the rest of the blood is returned. Some participants may provide a specimen via apheresis one time (the "apheresis group") and then elect to provide a second optional specimen via a standard blood draw (the "blood draw group") or vice versa.
Interventions
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Blood Draw
Participants have a standard blood draw or apheresis on study. Some participants may provide a specimen via apheresis one time (the "blood draw group") and then elect to provide a second optional specimen via a standard blood draw (the "apheresis draw group") or vice versa.
Apheresis
Participants have a standard blood draw or apheresis on study. Apheresis is a procedure where blood is drawn from your body, specific components like plasma, platelets, and/or white blood cells are separated out, and the rest of the blood is returned. Some participants may provide a specimen via apheresis one time (the "apheresis group") and then elect to provide a second optional specimen via a standard blood draw (the "blood draw group") or vice versa.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to provide mandatory research blood draw or apheresis per protocol
* Provide written informed consent
* The following laboratory values obtained ≤ 28 days prior to registration
* Hemoglobin ≥10.0 g/dl
* Absolute neutrophil count (ANC) ≥1500/mm\^3
* Platelet count ≥100,000/mm\^3
Exclusion Criteria
* IV antibiotic ≤2 weeks prior to apheresis
* Major Surgery ≤4 weeks prior to registration
* Received a live vaccine ≤30 days prior to registration
* Active hematologic malignancies ≤ 3 years prior to registration
* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
* History of active tuberculosis (TB), human immunodeficiency virus (HIV), active hepatitis B (e.g., HBsAg reactive), and/or active hepatitis C infection \[e.g., Hepatitis C Virus (HCV) ribonucleic acid (RNA) qualitative is detected)
* Known history of active autoimmune disease that has required systemic treatment in the ≤14 days (i.e., with the use of disease-modifying agents, corticosteroids \>10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to registration.
* NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Keith Knutson, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Central Contacts
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Cancer Center Clinical Trials
Role: CONTACT
Phone: 507-293-6386
Facility Contacts
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Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-011832
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2025-06055
Identifier Type: OTHER
Identifier Source: secondary_id
MC240903
Identifier Type: -
Identifier Source: org_study_id