Connect® Myeloid Disease Registry
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
Connect® MDS/AML Registry (primary)
The purpose of the Connect® Myeloid disease registry is to provide unique insights into
treatment decisions and treatment patterns as they relate to clinical outcomes of patients
with myeloid diseases in routine clinical practice. This disease registry will also evaluate
molecular and cellular markers that may provide further prognostic classification which may
or may not be predictive of therapy and clinical outcomes.
This Disease Registry will collect data on patient characteristics, treatment patterns and
clinical outcomes. The objective is to describe how patients with myeloid diseases are
treated; and to build a knowledge base regarding the effectiveness and safety of first line
and subsequent treatment regimens in both community and academic settings. Enrolled patients
will receive treatment and evaluations for their disease according to the standard of care
and routine clinical practice at each study site. All treatments that patients receive for
their disease will be recorded, including initial treatment and any subsequent therapy. Data
on treatment outcomes, including response rates as measured by the treating physician,
evidence of progression, survival, and patient-reported outcomes will be collected quarterly
on the electronic CRF.
- Patients must be able to provide written informed consent form (ICF)
- Must be willing and able to complete baseline and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish
- AML patients must be at least 55 years of age at the time of informed consent.
- MF, ICUS, and MDS patients must be at least 18 years of age at the time of informed consent. Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML) patients:
- Newly diagnosed primary or secondary disease. To be considered "newly diagnosed", a patient's confirmed diagnosis must be made no more than 60 days prior to the date of consent signature. (An additional 5-day window [i.e., up to 65 days prior to the date of ICF signature] may be allowed in special circumstance upon sponsor approval)
- Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site. Myelofibrosis (MF) patients:
- Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 60 days prior to the date of consent signature. This cohort allows the enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferative overlap syndromes (MDS/MPN overlap syndrome).
- Cohort assignment is confirmed by the site. Central eligibility review is not required.
Treatment Sites in Georgia
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