What's the purpose of this trial?
Background:
Myelodysplastic syndromes (MDS) occur when the cells that make blood cells are abnormal. There are limited treatment options for MDS. Researchers want to learn more through this natural history study so they can develop better treatments.
Objective:
To study the natural course of MDS and MDS/myeloproliferative neoplasms (MPN) and collect biological samples that can help researchers understand the disease.
Eligibility:
People with suspected or confirmed MDS or MDS/MPN. Healthy donors are also needed. They can be people who are scheduled to donate bone marrow at NIH for a relative, or they may be providing bone marrow in another study.
Design:
Participants will be screened with a medical history.
Participants will have a physical exam. They will give blood and urine samples. They will discuss their symptoms, medications, and ability to perform their normal activities. They will complete surveys about how they are feeling.
Participants will have a bone marrow biopsy. A needle will be inserted through a small cut. Bone marrow will be removed. A small piece of bone may be removed.
Participants may have an optional skin biopsy.
Participants may give optional saliva and stool samples. They may collect these samples at home and mail them to NIH.
Participants may undergo optional apheresis. One or two needles or intravenous (IV) lines will be placed in their arm, neck, or groin veins. Blood will be removed. A machine will separate out the white cells. The rest of the blood will be returned to the participant.
Participants will be contacted for follow-up once a year for up to 20 years.
Healthy donors will have marrow collected for this study during their scheduled procedure with no follow-up.
This trial is currently open and accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
* INCLUSION CRITERIA - MDS Participants
* Any gender, any age.
* Histologically or cytologically suspected or confirmed myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN), MDS/myeloproliferative neoplasm with ringed sideroblasts and thrombocytosis (MDS/MPN-RS-T), myelodysplastic syndromes/myeloproliferative neoplasms unclassified (MDS/MPN-U), chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), or secondary acute myeloid leukemia (sAML) with antecedent MDS or MDS/MPN.
* Participants may have had any amount of prior therapy and may be receiving MDSdirected therapy at time of enrollment.
* Participants must have an identified primary oncologist, hematologist or generalist outside of NIH who agrees to manage participant care and any diagnostic findings provided by this study.
INCLUSION CRITERIA - Marrow Control Donor Participants
* Any gender, and must be eligible for marrow donation per NIH Clinical Center requirements.
* No history of hematological malignancies as listed as inclusion in 'Inclusion Criteria - MDS Participants' or current autoimmune disease.
* Must be scheduled for bone marrow harvest for clinical application (e.g., marrow donation); or, if being evaluated for malignancy, have a clinical bone marrow aspirate scheduled (e.g., to rule out bone marrow involvement).
INCLUSION CRITERIA - All Participants
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Ability of participant or parent/guardian to understand and the willingness to sign a written consent document.
EXCLUSION CRITERIA - All Participants
-Uncontrolled intercurrent illness, psychiatric illness, or other that would limit compliance with study requirements, or at the investigator s discretion.
Additional Trial Information
Observational Trial
Enrollment: 1,100 patients (estimated)
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