Connect® MDS/AML Disease Registry
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|ClinicalTrials.gov Identifier: NCT01688011|
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : November 6, 2017
|Condition or disease|
|Myelodysplastic Syndromes Acute Myeloid Leukemia|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry|
|Study Start Date :||December 12, 2013|
|Estimated Primary Completion Date :||December 12, 2018|
|Estimated Study Completion Date :||December 12, 2026|
Lower-Risk Myelodysplastic Syndromes (LR MDS)
Newly diagnosed lower risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Higher-Risk Myelodysplastic Syndromes (HR MDS)
Newly diagnosed higher risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Acute Myeloid Leukemia (AML)
Newly diagnosed AML patients (≥55 years old, excluding patients with acute promyelocytic leukemia (APL).
Idiopathic Cytopenia of Undetermined Significance (ICUS)
Newly diagnosed ICUS patients as determined by clinical criteria defined by Valent et al.
- Patient Demographics [ Time Frame: Up to 8 years ]Describe patient demographics and clinical outcomes of patients with LR or HR MDS, ICUS, and AML
- Diagnostic and Treatment Patterns [ Time Frame: Up to 8 years ]Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients with LR or HR MDS, ICUS, and AML
- Safety and Effectiveness [ Time Frame: Up to 8 years ]Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events.
- Patient Reported Outcome [ Time Frame: Up to 8 years ]Summarize patient reported outcomes (including e.g., Health-Related Quality of Life (HRQOL)) and economic outcomes, and their association with patient characteristics, treatment regimens, and clinical outcomes
- Correlative Studies [ Time Frame: Up to 8 years ]Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688011
|Contact: Melissa Nifeneckeremail@example.com|
Show 215 Study Locations
|Study Director:||Han Myint, MD||Celgene Corporation|