Connect® MDS/AML Disease Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01688011|
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : April 14, 2020
|Condition or disease|
|Myelodysplastic Syndromes Acute Myeloid Leukemia|
|Study Type :||Observational|
|Estimated Enrollment :||2100 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, 2022|
|Estimated Study Completion Date :||December 12, 2030|
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).
Newly diagnosed unknown-risk MDS patients as determined by International Prognostic Scoring System (IPSS); defined as not having risk assigned due to unsuccessful cytogenetics after two bone marrow attempts.
- Patient Demographics [ Time Frame: Up to 8 years ]Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, MDS risk not determined, 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, MDS risk not determined, 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688011
|Contact: Melissa Nifeneckerfirstname.lastname@example.org|
|Study Director:||Chrystal Louis, MD||Bristol-Myers Squibb|
|Study Director:||Oleg Zernovak, M.D.||Celgene Corporation|