Current Clinical Trials

The National Myelodysplastic Syndromes (MDS) Study
  1. Constantin Dasanu, MD, PhD
    Constantin Dasanu, MD, PhD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started January 2019
  5. Constantin Dasanu, MD, PhD
  6. Accepting new patients

Description

Summary

The National Myelodysplastic Syndromes Natural History Study (The National MDS Study) is a prospective cohort study to establish a publicly available resource to facilitate the understanding of the natural history of myelodysplastic syndromes (MDS). This will be accomplished by creating a standardized clinical dataset linked to a prospectively collected, consistently processed, and well-characterized biospecimen repository derived from up to 2,000 participants with MDS or MDS/myeloproliferative neoplasm (MPN) overlap and up to 500 participants with ICUS. The establishment of this national resource will enable scientists to address research questions in MDS that have been impractical to study through single or multi-institutional cooperative efforts, through retrospective studies, or through other disease registries. The National MDS Study will facilitate the understanding of MDS pathogenesis and progression; enhance MDS diagnosis, classification, prognosis, and survivorship; inform medical decision making for MDS patients; facilitate biomarker discovery; help identify new therapeutic targets as well as define the optimal use of existing therapies; and inform efforts to understand disease etiology and prevention. This publicly funded resource will be made available to the broader scientific community interested in MDS research. Such efforts will likely include genetics studies. Inclusion of the ICUS group will provide insights to such questions as: Are the number and types of clonally restricted somatic mutations different than MDS patients at entry? Do individuals perceived quality of life differ between the two groups? Is there a difference in care utilization for early MDS and ICUS individuals?

Official Title

NHLBI-MDS: The National Myelodysplastic Syndromes (MDS) Study

Detailed Description

Multi-center, prospective cohort study enrolling patients from centers in the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP). The accrual period is 5+ years. After central pathology review of registered participants, approximately 2,000 cases of MDS or MDS/MPN overlap disorders, and 500 cases of ICUS will be identified for the longitudinal study cohort and up to 1000 cases will be identified for the cross-sectional coho... more
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Multi-center, prospective cohort study enrolling patients from centers in the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP). The accrual period is 5+ years. After central pathology review of registered participants, approximately 2,000 cases of MDS or MDS/MPN overlap disorders, and 500 cases of ICUS will be identified for the longitudinal study cohort and up to 1000 cases will be identified for the cross-sectional cohort. No more than 3500 total participants will be registered. Participants in the longitudinal cohort may be followed for life. The goal of the National MDS Study is to establish a publicly available resource to facilitate the study of MDS natural history. This will be accomplished through: 1) Creation of a multi-institutional, longitudinal collection of consistently processed and clinically well-annotated blood and tissue specimens collected prospectively from participants with MDS and participants with idiopathic cytopenia of undetermined significance (ICUS); and 2) Support for investigator-initiated studies of MDS that will have high-impact for MDS patients, including basic science, clinical, health outcomes and epidemiological research.

Keywords

Myelodysplastic Syndromes (MDS)

Eligibility

for people 18 Years and up
Inclusion Criteria: Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.) MDS or MDS/MPN overlap disorders and undergoing diagnostic work-up with planned bone marrow assessments, or diagnosed with de novo or therapy-related MDS within 12 months of enrollment per the World Health Organization (WHO) criteria1 and undergoing clinical evaluation and planned bone marrow assessments to confirm MDS or to evaluate disease status Bone marrow aspirate expected to be perfor... more
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Inclusion Criteria: Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.) MDS or MDS/MPN overlap disorders and undergoing diagnostic work-up with planned bone marrow assessments, or diagnosed with de novo or therapy-related MDS within 12 months of enrollment per the World Health Organization (WHO) criteria1 and undergoing clinical evaluation and planned bone marrow assessments to confirm MDS or to evaluate disease status Bone marrow aspirate expected to be performed within 1 week of registration, and in all cases must be performed no later than 4 weeks after enrollment Age 18 or older If anemic without prior MDS diagnosis, B12 level, serum folate, mean corpuscular volume (MCV), red cell distribution width (RDW), ferritin, and iron studies (Iron, total iron-binding capacity (TIBC) test, and percent saturation) must be performed within prior 6 months. Exclusion Criteria: Prior treatment for MDS at entry and through the time of the entry bone marrow aspirate Treatment with hematopoietic growth factors in prior 6 months Diagnosis of a solid tumor or hematologic malignancy within two years prior to enrollment except for in situ cancer of the skin (basal or squamous cell), cervix, bladder, breast, or prostate Treatment with radiation therapy in the two years prior to registration Non-hormonal treatment for malignancy within the two years prior to registration Established hereditary bone marrow failure syndrome Known primary diagnosis of aplastic anemia, classical paroxysmal nocturnal hemoglobinuria, amegakaryocytic thrombocytopenic purpura, or large granular lymphocyte leukemia Enrolled in the Connect® MDS/AML Disease Registry (NCT01688011)

Lead Scientists at Eisenhower Health

Constantin Dasanu, MD, PhD
Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicin... more
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Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicine in New York and his fellowship in Hematology/Oncology at New York Medical College. Dr. Dasanu also completed his training in Hematology & Transfusion Medicine in his home country Romania. 

“My immunology background offers me a unique clinical perspective as contemporary cancer therapies include a multitude of targeted agents, monoclonal antibodies, various biologics and vaccines,” states Dr. Dasanu. He treats patients with a variety of solid cancers, malignant melanoma and blood conditions. He serves as Director of Hematologic Malignancies at Eisenhower Lucy Curci Cancer Center (ELCCC). 

Dr. Dasanu is a Clinical Professor of Medicine at the University of California in San Diego, a major collaborative affiliate of ELCCC. He is the Director of Research at ELCCC and a principal investigator for a number of clinical trials. He presents his research findings at national and international conferences. He is the recipient of several teaching awards including the prestigious Thomas R. Preston MD Excellence in Teaching Award at the University of Connecticut in 2011. 

A prolific medical writer, Dr. Dasanu published more than 200 scientific and scholarly articles in prominent specialty journals including Journal of Clinical Oncology, New England Journal of Medicine, Journal of Thoracic Oncology and British Journal of Haematology among others. He is the editor of oncology sections at the Expert Opinion on Pharmacotherapy, Expert Opinion on Biological Therapy, and Current Medical Research and Opinion. He is a peer reviewer for Blood Journal and Leukemia Research. 

Armed with the knowledge of science, Dr. Dasanu feels that he can make a real difference in the lives of his patients. “The field is constantly changing and, therefore, I keep learning and constantly applying the most up-to-date, state-of-the-art treatments which ultimately benefit my patients,” states Dr. Dasanu. “My role is one of providing my patients with a medical plan that offers hope, but not false hope. Treating patients as unique individuals, with respect and compassion, and treating them as I would want to be treated are my ultimate goals in patient care.”

Clinical Study Details

  1. Accepting new patients
  2. study started January 2019
  3. Observational
  4. April 04, 2024