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Trial record 1 of 1 for:    NCT02775383
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The National Myelodysplastic Syndromes (MDS) Study (MDS)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by National Heart, Lung, and Blood Institute (NHLBI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT02775383
First received: May 2, 2016
Last updated: January 9, 2017
Last verified: December 2016
  Purpose
Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed long term. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the study of the natural history of MDS.

Condition Intervention
Myelodysplastic Syndromes (MDS) Other: Therapeutic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The National Myelodysplastic Syndromes Natural History Study

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Number of patients dying [ Time Frame: Through study completion, an average of 3 years ]
    Deaths will be reported on study case report forms


Secondary Outcome Measures:
  • Number of participants progressing to Acute Myeloid Leukemia (AML) [ Time Frame: Through study completion, an average of 3 years ]
    Progression to AML will be reported on study case report forms


Biospecimen Retention:   Samples With DNA
bone marrow, peripheral blood, serum, plasma, eyebrow hairs with attached follicles, buccal cells, skin biopsy

Estimated Enrollment: 3500
Study Start Date: April 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Longitudinal
Participants with MDS, MDS/MPN overlap disorder, or ICUS who are followed long term
Other: Therapeutic
Observational Study
Cross-sectional
Participants who do not have MDS, MDS/MPN overlap disorder, or ICUS and have the baseline visit only
Other: Therapeutic
Observational 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected MDS or MDS/MPN overlap disorder who are undergoing diagnostic workup and bone marrow assessments, and patients diagnosed with MDS within 6-months of enrollment and undergoing clinical evaluation and bone marrow assessments to confirm MDS or evaluate disease status
Criteria

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 6-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
  • B12 level, serum folate, ferritin, and Thyroid-Stimulating Hormone (TSH) tests performed in 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02775383

Contacts
Contact: Brianna Johnson bjohnson@emmes.com

  Show 145 Study Locations
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Investigators
Study Chair: Mikkael Sekeres, MD, MS The Cleveland Clinic
Study Chair: Steven Gore, MD Yale University
  More Information

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02775383     History of Changes
Other Study ID Numbers: NHLBI-MDS
Study First Received: May 2, 2016
Last Updated: January 9, 2017

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
National MDS Study
MDS
Idiopathic
cytopenia
cytopenias
ICUS
MDS/MPN
Myeloproliferative Neoplasm
Biorepository

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2017