The National MDS Natural History Study: design of an integrated data and sample biorepository to promote research studies in myelodysplastic syndromes

References

• Jacobs RH, Cornbleet MA, Vardiman JW, et al. Prognostic implications of morphology and karyotype in primary myelodysplastic syndromes. Blood. 1986;67:1765–1772.
   PubMed Web of Science ®Google Scholar
• Kao JM, McMillan A, Greenberg PL. International MDS risk analysis workshop (IMRAW)/IPSS reanalyzed: impact of cytopenias on clinical outcomes in myelodysplastic syndromes. Am J Hematol. 2008;83:765–770.
   PubMed Web of Science ®Google Scholar
• Greenberg P, Anderson J, de Witte T, et al. Problematic WHO reclassification of myelodysplastic syndromes. Members of the International MDS Study Group. J Clin Oncol. 2000;18:3447–3452.
   PubMed Web of Science ®Google Scholar
• Greenberg P, Cox C, LeBeau MM, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997;89:2079–2088.
   PubMed Web of Science ®Google Scholar
• Maes B, Meeus P, Michaux L, et al. Application of the International Prognostic Scoring System for myelodysplastic syndromes. Ann Oncol. 1999;10:825–829.
   PubMed Web of Science ®Google Scholar
• Schanz J, Tuchler H, Sole F, et al. New comprehensive cytogenetic scoring system for primary myelodysplastic syndromes (MDS) and oligoblastic acute myeloid leukemia after MDS derived from an international database merge. J Clin Oncol. 2012;30:820–829.
   PubMed Web of Science ®Google Scholar
• Obama B. The genomics and Personalized Medicine Act of 2006. Clin Adv Hematol Oncol. 2007;5:39–40.
   PubMedGoogle Scholar
• Overby CL, Tarczy-Hornoch P. Personalized medicine: challenges and opportunities for translational bioinformatics. Per Med. 2013;10:453–462.
   PubMed Web of Science ®Google Scholar
• Vaught J, Rogers J, Myers K, et al. An NCI perspective on creating sustainable biospecimen resources. J Natl Cancer Inst Monogr. 2011;2011:1–7.
   PubMedGoogle Scholar
• Greenberg PL, Stone RM, Al-Kali A, et al. Myelodysplastic Syndromes, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Net. 2017;15:60–87.
   PubMed Web of Science ®Google Scholar
• Plasilova M, Risitano A, Maciejewski JP. Application of the molecular analysis of the T-cell receptor repertoire in the study of immune-mediated hematologic diseases. Hematology. 2003;8:173–181.
   PubMedGoogle Scholar
• Sanz GF, Sanz MA, Greenberg PL. Prognostic factors and scoring systems in myelodysplastic syndromes. Haematologica. 1998;83:358–368.
   PubMed Web of Science ®Google Scholar
• Rotenstein LS, Huckman RS, Wagle NW. Making patients and doctors happier - the potential of patient-reported outcomes. N Engl J Med. 2017;377:1309–1312.
   PubMed Web of Science ®Google Scholar
• LeBlanc TW, Abernethy AP. Patient-reported outcomes in cancer care - hearing the patient voice at greater volume. Nat Rev Clin Oncol. 2017;14:763–772.
   PubMed Web of Science ®Google Scholar
• Basch EM, Deal AM, Dueck AC, et al. Overall survival results of a randomized trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318:197–198
   PubMed Web of Science ®Google Scholar
• Yang LY, Manhas DS, Howard AF, et al. Patient-reported outcome use in oncology: a systematic review of the impact on patient-clinician communication. Support Care Cancer. 2018;26:41–60.
   PubMed Web of Science ®Google Scholar
• Kwok B, Hall JM, Witte JS, et al. MDS-associated somatic mutations and clonal hematopoiesis are common in idiopathic cytopenias of undetermined significance. Blood. 2015;126:2355–2361.
   PubMed Web of Science ®Google Scholar
• Schroeder T, Ruf L, Bernhardt A, et al. Distinguishing myelodysplastic syndromes (MDS) from idiopathic cytopenia of undetermined significance (ICUS): HUMARA unravels clonality in a subgroup of patients. Ann Oncol. 2010;21:2267–2271.
   PubMed Web of Science ®Google Scholar
• Steensma DP, Bejar R, Jaiswal S, et al. Clonal hematopoiesis of indeterminate potential and its distinction from myelodysplastic syndromes. Blood. 2015;126:9–16.
   PubMed Web of Science ®Google Scholar
• Singleton TP, Yin B, Teferra A, et al. Spectrum of clonal large granular lymphocytes (LGLs) of alphabeta T cells: T-cell clones of undetermined significance, T-cell LGL leukemias, and T-cell immunoclones. Am J Clin Pathol. 2015;144:137–144.
   PubMed Web of Science ®Google Scholar
• McCaskill-Stevens W, Lyss AP, Good M, et al. The NCI Community Oncology Research Program: what every clinician needs to know. Am Soc Clin Oncol Edu. 2013. DOI:10.1200/EdBook_AM.2013.33.e84
   PubMedGoogle Scholar
• Grubbs SS. The new national cancer institute national clinical trials network. Am Soc Clin Oncol Edu. 2012;146–148.
   PubMedGoogle Scholar
• Donovan C. CTSU provides tools that link research and practice. ONS News. 2001;16:14–15.
   PubMedGoogle Scholar
• Comis RL, Schnall MD. Opportunities for the ECOG-ACRIN Cancer Research Group within the new National Clinical Trials Network. Semin Oncol. 2015;42:1–3.
   PubMed Web of Science ®Google Scholar
• Bennett JM. Changes in the Updated 2016: WHO classification of the myelodysplastic syndromes and related myeloid neoplasms. Clin Lymphoma Myeloma Leuk. 2016;16:607–609.
   PubMed Web of Science ®Google Scholar
• Sekeres MA, Othus M, List AF, et al. Randomized Phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American intergroup study SWOG S1117. J Clin Oncol. 2017;35:2745–2753.
   PubMed Web of Science ®Google Scholar
• Prorok PC, Andriole GL, Bresalier RS, et al. Design of the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial. Control Clin Trials. 2000;21:273S–309S.
   PubMedGoogle Scholar
• Abel GA, Efficace F, Buckstein RJ, et al. Prospective international validation of the quality of life in myelodysplasia scale (QUALMS). Haematologica. 2016;101:781–788.
   PubMed Web of Science ®Google Scholar
• Overcash J, Extermann M, Parr J, et al. Validity and reliability of the FACT-G scale for use in the older person with cancer. Am J Clin Oncol. 2001;24:591–596.
   PubMed Web of Science ®Google Scholar
• Abel GA, Buckstein R. Integrating frailty, comorbidity, and quality of life in the management of myelodysplastic syndromes. Am Soc Clin Oncol Edu. 2016;35:e337–344.
   PubMedGoogle Scholar
• Abel GA, Klaassen R, Lee SJ, et al. Patient-reported outcomes for the myelodysplastic syndromes: a new MDS-specific measure of quality of life. Blood. 2014;123:451–452.
   PubMed Web of Science ®Google Scholar
• Saliba D, Elliott M, Rubenstein LZ, et al. The Vulnerable Elders Survey: a tool for identifying vulnerable older people in the community. J Am Geriatr Soc. 2001;49:1691–1699.
   PubMed Web of Science ®Google Scholar
• Francois P, Lecoanet A, Caporossi A, et al. Experience feedback committees: a way of implementing a root cause analysis practice in hospital medical departments. PLoS One. 2018;13:e0201067.
   PubMed Web of Science ®Google Scholar
• Dugan L, Leech L, Speroni KG, et al. Factors affecting hemolysis rates in blood samples drawn from newly placed IV sites in the emergency department. J Emerg Nurs. 2005;31:338–345.
   PubMed Web of Science ®Google Scholar
• Ross JS, Ritchie JD, Finn E, et al. Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users. BMJ Open. 2016;6:e012769.
   PubMed Web of Science ®Google Scholar
• Makishima H, LaFramboise T, Przychodzen B, et al. Clinical “MUTATOME” of myelodysplastic syndrome; comparison to primary acute myelogenous leukemia. Blood. 2013;122:518.
   Web of Science ®Google Scholar
• Brucker PS, Yost K, Cashy J, et al. General population and cancer patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Eval Health Prof. 2005;28:192–211.
   PubMed Web of Science ®Google Scholar
• Zhang L, Stablein DM, Epling-Burnette P, et al. Diagnosis of myelodysplastic syndromes and related conditions: rates of discordance between local and central review in the NHLBI MDS Natural History Study. Blood. 2018;132:4370
   Web of Science ®Google Scholar
• Mohamedali AM, Gaken J, Ahmed M, et al. High concordance of genomic and cytogenetic aberrations between peripheral blood and bone marrow in myelodysplastic syndrome (MDS). Leukemia. 2015;29:1928–1938.
   PubMed Web of Science ®Google Scholar
• Papaemmanuil E, Gerstung M, Malcovati L, et al. Clinical and biological implications of driver mutations in myelodysplastic syndromes. Blood. 2013;122:3616–3627.
   PubMed Web of Science ®Google Scholar
• Padron E, Ball MC, Teer JK, et al. Germ line tissues for optimal detection of somatic variants in myelodysplastic syndromes. Blood. 2018;131:2402–2405.
   PubMed Web of Science ®Google Scholar
• Zandberg DP, Hendrick F, Vannorsdall E, et al. Tertiary center referral patterns for patients with myelodysplastic syndrome are indicative of age and race disparities: a single-institution experience. Leuk Lymphoma. 2013;54:304–309.
   PubMed Web of Science ®Google Scholar