Ethics Committees/Review Boards Which Approved the Connect MDS/AML Study. A list of all Institutional Review Boards that have approved the Connect MDS/AML Disease Registry study. (DOCX 17 kb

Arlene Swern (3489893)

Bart Scott (3489929)

Christopher Cogle (3489923)

Daniel Pollyea (3489920)

David Grinblatt (3489896)

David Steensma (3489890)

Guillermo Garcia-Manero (407501)

Harry Erba (640535)

Jaroslaw Maciejewski (3489908)

Kathryn Foucar (3489902)

Mary Sugrue (3489926)

Medrdad Abedi (3489899)

Melissa Nifenecker (3489932)

Michael Savona (3489905)

Michael Thompson (348965)

Mikkael Sekeres (3489917)

Rafael Bejar (3489935)

Rami Komrokji (3489914)

Tracy George (3489911)

Xiaomei Ma (615999)

BMC Cancer

PubMed

David P. Steensma

Medrdad Abedi

Rafael Bejar

Christopher R. Cogle

Kathryn Foucar

Guillermo Garcia-Manero

Tracy I. George

David Grinblatt

Rami Komrokji

Xiaomei Ma

Jaroslaw Maciejewski

Daniel A. Pollyea

Michael R. Savona

Bart Scott

Mikkael A. Sekeres

Michael A. Thompson

Arlene S. Swern

Melissa Nifenecker

Mary M. Sugrue

Harry Erba

Crossref

Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study

Steensma, David P.

Abedi, Medrdad

Bejar, Rafael

Cogle, Christopher R.

Foucar, Kathryn

Garcia-Manero, Guillermo

George, Tracy I.

Grinblatt, David

Komrokji, Rami

Ma, Xiaomei

Maciejewski, Jaroslaw

Pollyea, Daniel A.

Savona, Michael R.

Scott, Bart

Sekeres, Mikkael A.

Thompson, Michael A.

Swern, Arlene S.

Nifenecker, Melissa

Sugrue, Mary M.

Erba, Harry

University of Miami: Scholarship Miami

BACKGROUND: Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are myeloid neoplasms in which outgrowth of neoplastic clones disrupts normal hematopoiesis. Some patients with unexplained persistent cytopenias may not meet minimal diagnostic criteria for MDS but an alternate diagnosis is not apparent; the term idiopathic cytopenia of undetermined significance (ICUS) has been used to describe this state. MDS and AML occur primarily in older patients who are often treated outside the clinical trial setting. Consequently, our understanding of the patterns of diagnostic evaluation, management, and outcomes of these patients is limited. Furthermore, there are few natural history studies of ICUS. To better understand how patients who have MDS, ICUS, or AML are managed in the routine clinical setting, the Connect MDS/AML Disease Registry, a multicenter, prospective, observational cohort study of patients newly diagnosed with these conditions has been initiated.
METHODS/DESIGN: The Connect MDS/AML Disease Registry will capture diagnosis, risk assessment, treatment, and outcomes data for approximately 1500 newly diagnosed patients from approximately 150 community and academic sites in the United States in 4 cohorts: (1) lower-risk MDS (International Prognostic Scoring System [IPSS] low and intermediate-1 risk), with and without del(5q); (2) higher-risk MDS (IPSS intermediate-2 and high risk); (3) ICUS; and (4) AML in patients aged ≥ 55 years (excluding acute promyelocytic leukemia). Diagnosis will be confirmed by central review. Baseline patient characteristics, diagnostic patterns, treatment patterns, clinical outcomes, health economics outcomes, and patient-reported health-related quality of life will be entered into an electronic data capture system at enrollment and quarterly for 8 years. A tissue substudy to explore the relationship between karyotypes, molecular markers, and clinical outcomes will be conducted, and is optional for patients.
DISCUSSION: The Connect MDS/AML Disease Registry will be the first prospective, observational, non-interventional study in the United States to collect clinical information, patient-reported outcomes, and tissue samples from patients with MDS, ICUS, or AML receiving multiple therapies. Results from this registry may provide new insights into the relationship between diagnostic practices, treatment regimens, and outcomes in patients with these diseases and identify areas for future investigation.
TRIAL REGISTRATION: Connect MDS/AML Disease Registry ( NCT01688011 ). Registered 14 September 2012

Steensma, David P

Abedi, Medrdad

Bejar, Rafael

Cogle, Christopher R

Foucar, Kathryn

Garcia-Manero, Guillermo

George, Tracy I

Grinblatt, David

Komrokji, Rami

Ma, Xiaomei

Maciejewski, Jaroslaw

Pollyea, Daniel A

Savona, Michael R

Scott, Bart

Sekeres, Mikkael A

Thompson, Michael A

Swern, Arlene S

Nifenecker, Melissa

Sugrue, Mary M

Erba, Harry

Aurora Health Care Digital Repository

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