Dataset Information

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect^® MDS/AML Disease Registry.

ABSTRACT: Diagnostic and molecular genetic testing are key in advancing the treatment of acute myeloid leukemia (AML), yet little is known about testing patterns outside of clinical trials, especially in older patients. We analyzed diagnostic and molecular testing patterns over time in 565 patients aged ≥ 55 years with newly diagnosed AML enrolled in the Connect^® MDS/AML Disease Registry (NCT01688011) in the United States. Diagnostic data were recorded at enrolment and compared with published guidelines. The percentage of bone marrow blasts was reported for 82.1% of patients, and cellularity was the most commonly reported bone marrow morphological feature. Flow cytometry, karyotyping, molecular testing, and fluorescence in situ hybridization were performed in 98.8%, 95.4%, 75.9%, and 75.7% of patients, respectively. Molecular testing was done more frequently at academic than community/government sites (84.3% vs 70.2%; P < .001). Enrolment to the Registry after 2016 was significantly associated with molecular testing at academic sites (odds ratio [OR] 2.59; P = .023) and at community/government sites (OR 4.85; P < .001) in logistic regression analyses. Better understanding of practice patterns may identify unmet needs and inform institutional protocols regarding the diagnosis of patients with AML.

SUBMITTER: Pollyea DA

PROVIDER: S-EPMC9176048 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect<sup>®</sup> MDS/AML Disease Registry.

Pollyea Daniel A DA George Tracy I TI Abedi Mehrdad M Bejar Rafael R Cogle Christopher R CR Foucar Kathryn K Garcia-Manero Guillermo G Grinblatt David L DL Komrokji Rami S RS Maciejewski Jaroslaw P JP Revicki Dennis A DA Roboz Gail J GJ Savona Michael R MR Scott Bart L BL Sekeres Mikkael A MA Thompson Michael A MA Kurtin Sandra E SE Louis Chrystal U CU Nifenecker Melissa M Flick E Dawn ED Swern Arlene S AS Kiselev Pavel P Steensma David P DP Erba Harry P HP

EJHaem 20200630 1

Diagnostic and molecular genetic testing are key in advancing the treatment of acute myeloid leukemia (AML), yet little is known about testing patterns outside of clinical trials, especially in older patients. We analyzed diagnostic and molecular testing patterns over time in 565 patients aged ≥ 55 years with newly diagnosed AML enrolled in the Connect<sup>®</sup> MDS/AML Disease Registry (NCT01688011) in the United States. Diagnostic data were recorded at enrolment and compared with published g ...[more]

PMID: 35847712

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Project description:BackgroundMyelodysplastic 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/designThe 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.DiscussionThe 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 registrationConnect MDS/AML Disease Registry ( NCT01688011 ). Registered 14 September 2012.

Dataset Information

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect^® MDS/AML Disease Registry.

Publications

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect<sup>®</sup> MDS/AML Disease Registry.

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Dataset Information

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect® MDS/AML Disease Registry.

Publications

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect<sup>®</sup> MDS/AML Disease Registry.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect^® MDS/AML Disease Registry.