NCI ID NCI-2016-00281
NCT ID NCT02775383
CTEP ID NHLBI-MDS
Primary Purpose OTHER
Anatomic Sites Multiple
Minimum Age 18 Years
Maximum Age 999 Years
Gender BOTH
Lead Org ECOG-ACRIN Cancer Research Group
Principal Investigator Mikkael Aaron Sekeres
NCI Site View on ClinicalTrials.gov

Tissue Collection and Natural History Study of Patients with Myelodysplastic Syndrome or Myeloproliferative Neoplasms

This research trial collects tissue samples from and studies the history of patients with myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN). Collecting and storing patients' bone marrow, blood, eyebrow hairs, buccal swab, skin, or other tissues to be studied in the laboratory in the future may help doctors learn more about MDS and blood disorders that may lead to MDS. Collecting information about patients and the treatments they receive may allow doctors to better understand how MDS changes over time and this knowledge may lead to better ways to prevent, detect, and treat MDS in the future.

Eligibility

Inclusion Criterea

  • 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) criteria 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
  • No prior treatment for MDS at entry and through the time of the entry bone marrow aspirate
  • No treatment with hematopoietic growth factors in prior 6 months
  • If anemic without prior MDS diagnosis, the following tests within the prior 6 months; values that are significantly outside of normal range do not exclude participation but should prompt investigation of alternative etiologies for anemia * B12 level * Serum folate * Mean corpuscular volume (MCV) * Red cell distribution width (RDW) * Ferritin * Iron studies (iron, total iron-binding capacity [TIBC] test, percent saturation)
  • No 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
  • No treatment with radiation therapy in the two years prior to registration
  • No non-hormonal treatment for malignancy within the two years prior to registration
  • No established hereditary bone marrow failure syndrome
  • No known primary diagnosis of aplastic anemia, classical paroxysmal nocturnal hemoglobinuria, amegakaryocytic thrombocytopenic purpura, or large granular lymphocyte leukemia
  • Not enrolled in the Connect MDS/Acute Myeloid Leukemia (AML) Disease Registry
  • In participants with suspected MDS and prior to registration with subsequent bone marrow evaluation, alternative causes for the cytopenias should be considered (e.g., internal bleeding, autoimmune cytopenias, thyroid disorders, other causes of anemia etc.); in select individuals, the following tests could be performed to assist in the diagnostic work-up; these evaluations are not required by the protocol; however, abnormal results in advance of enrollment may reduce the number of non-MDS cases * Copper, serum level * Direct antiglobulin test * Antinuclear antibody (ANA) test * Creatinine * Calculated glomerular filtration rate (GFR) * Thyroid-stimulating hormone (TSH) tests performed in prior 6 months ** Based on centralized pathology review, participants will be classified into the longitudinal cohort of cases (MDS; MDS/MPN overlap disorders; AML with < 30% blasts without core binding factor or acute promyelocytic leukemia [AML < 30% blasts including chromosomal rearrangements between chromosomes 8 and 21 and within chromosome 16 as well as t(15;17)]; idiopathic cytopenia of undetermined significance [ICUS], or at risk based on selected genetic markers) and the cross-sectional cohort (all others); it is not known in advance what percentages of individuals will fall into each cohort; in addition to baseline biological samples, longitudinal samples and data will be collected for approximately 2000 cases of MDS or MDS/MPN overlap disorders and 500 cases of ICUS assigned to the longitudinal cohort; sample and data collection will cease at baseline for all cases assigned to the cross-sectional cohort; submitted samples will be reviewed by a central pathologist to determine eligibility for the longitudinal cohort (i.e., an MDS, MDS/MPN, AML with < 30% blasts without core binding factor or acute promyelocytic leukemia, or ICUS diagnosis); should a discrepancy in diagnosis occur between the central review and study site, the study site will be notified to allow for additional information to be submitted to clarify the diagnosis; such notifications will not occur in real time, and are not intended to assist in patient care; additional central sequencing of selected genetic targets will be performed

Exclusion Criterea


Participating Clinics

OptumCare Cancer Care at Fort Apache


6190 South Fort Apache Road
Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley


3730 South Eastern Avenue
Las Vegas, NV 89169
Map

702-384-0013
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation


One Breakthrough Way
Las Vegas, NV 89135
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada


9280 West Sunset Road
Suite 100 Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest


7445 Peak Drive
Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at MountainView


3150 North Tenaya Way
Suite 510 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada


6827 West Tropicana Avenue
Suite 110 Las Vegas, NV 89103
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston


2300 West Charleston Boulevard
Las Vegas, NV 89102
Map

702-384-0013

OptumCare Cancer Care at Seven Hills


3175 Saint Rose Parkway
Suite 200 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Valley Medical Center


400 South 43rd Street
Renton, WA 98055
Map

425-228-3440
research@valleymed.org