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Upstate Active Clinical Trials

Study Title:

Cold Agglutinin Disease Real World Evidence Registry

What is the purpose of the study? (in Layman's terms, please describe the study)

The aim of this registry is to develop a large, international database of patients with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS) to better understand patient and clinical characteristics, complications, long-term clinical and patient-reported outcomes associated with the different CAD and CAS treatments and health-resource utilization, and to help raise awareness of CAD and CAS and their management.
In addition, the study will include a drug registry component to assess the safety and the effectiveness of sutimlimab in patients with CAD in a real-world setting.

Upstate Institutional Review Board (IRB) Number:

1572545

Study/Protocol ID:

OBS16454

Study Phase:

Registry

Patient Age Group:

Adults

Principal Investigator:

Bernard J Poiesz, MD

Who is eligible?

Patient aged 18 or over, with a diagnosis of CAD or CAS , and able to understand the purpose of the study and who( or whose legally authorized representative) provide signed and dated informed consent.

Patient with mixed warm and cold, or warm, autoimmune hemolytic anemia are excluded. Patient actively participating in a CAD or CAS interventional clinical trial are excluded.

What is involved if I participate?

  • How long is the study?
    Patients will be followed up for up to 6 years (3 year enrollment period plus at least 3 years of follow-up for all patients).
  • Is transportation provided or reimbursed?
    No
  • Is parking provided or reimbursed?
    No
  • What tests and procedures are involved?
    Data (demographics, diagnosis, symptoms, lab results, medications, health utilization, etc.) will be collected during the normal course of patient care. Additionally, the patients will be asked to complete questionnaires when they are on site at around or longer than 6-months intervals upon routine visits.

Where will the study take place?

SUNY Upstate Medical University Downtown
SUNY Upstate Medical University Community
Upstate Cancer Center at Oneida
Upstate Cancer Center at Oswego

Other Information:

The CADENCE registry is an observational study and it will not affect the patient-Investigator relationship, or influence the Investigator's drug prescription or therapeutic management of the patient.

Who can I contact for more information?

Name: Patricia M Benz
Phone: 315-464-8253
Email: benzp@upstate.edu

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