Connect® MDS/AML Disease Registry
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|ClinicalTrials.gov Identifier: NCT01688011|
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : June 5, 2018
|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, 2020|
|Estimated Study Completion Date :||December 12, 2028|
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. (Valent P, Horny H-P, Bennett JM et al. 2007. Definitions and standards in the diagnosis and treatment of the myelodysplastic syndromes: Consensus statements and report from a working conference. Leukemia Research. 31: 727-736. And further updated Valent P, Bennett JM et al. 2017. Proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions. Oncotarget. 8(43): 73483-73500.)
- 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 Nifeneckerfirstname.lastname@example.org|
Show 219 Study Locations
|Study Director:||Chrystal Louis, MD||Celgene Corporation|