Comprehensive Molecular and Clinical Evaluation of Pediatric and Adult MDS

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05350748
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
1 Day - 120 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Aug 18, 2022
Status verified
May 2026
Primary completion
Sep 20, 2041
Completion
May 1, 2042

Study Design

Enrollment
1,100 participants (estimated)

Arms

  • Arm: Cohort 1
    Participants with myelodysplastic syndromes and associated malignancies
  • Arm: Cohort 2
    Participants (controls) without MDS or associated malignancies, contributing bone marrow

Primary Outcome Measure

characterize the natural history of myelodysplastic syndromes (MDS) and to assess overall and progression free survival [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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