Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 1 Day to 120 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 20 years
- Procedures mentioned: Physical exams, Urine samples, Questionnaires, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will have a physical exam."
- "They will give blood and urine samples."
- "They will complete surveys about how they are feeling."
- "Participants will have a bone marrow biopsy."
- "Participants may have an optional skin biopsy."
- "Participants will be contacted for follow-up once a year for up to 20 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study follows MDS and related diseases over time and collects samples to help researchers understand them. MDS affects the cells that make blood. Children and adults with these diseases or conditions that may lead to MDS can join, along with eligible bone marrow donors.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- People of any age or sex may join the MDS group.
- The MDS group must have suspected or confirmed MDS, a related blood cancer, or a condition that may lead to MDS, based on cell or tissue tests.
- People in the MDS group may have had any amount of past treatment and may still be getting treatment.
- People in the MDS group must have a doctor outside NIH who agrees to manage their care and any findings from the study.
- Donors may be of either sex and must meet NIH rules for bone marrow donation.
- Donors must have no history of the blood cancers listed for the MDS group and no current autoimmune disease, where the body attacks its own healthy cells.
- Donors must already be scheduled to give bone marrow for medical use or have a marrow sample taken during a cancer check.
- Everyone must be willing and available to follow study requirements. They or their parent or guardian must understand and sign a consent form.
Who can't join
- An illness that is not controlled, a mental health condition, or another problem that could prevent following study requirements.
- The study doctor may also decide that someone cannot join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA - MDS Participants * Either sex, 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), secondary acute myeloid leukemia (sAML) with antecedent MDS or MDS/MPN, or participants who have precursor conditions that are associated with a risk of progression to MDS, including but not limited to clonal hematopoiesis of indeterminate potential (CHIP) and clonal cytopenia of unknown significance (CCUS). * Participants may have had any amount of prior therapy and may be receiving MDS-directed 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 * Either sex, 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.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda