Myelodysplastic SyndromesNCT05588154
Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies
An observational study of Myelodysplastic Syndromes, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Myelodysplastic syndromes (MDS) are disorders of blood stem cells that can develop into blood cancers. Treatment options are limited. To find better treatments, researchers need to better understand how MDS develops. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelodysplastic Syndromes
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 1 Dec 2052
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are healthy volunteers, selected from the general population. Employees may also volunteer per the protocol.
Who may be able to join
- Age >= 18 years old
- Healthy volunteers; the following confirmed by the Principal Investigator or designees based on recent (within 3 months before study intervention(s))
- medical history
- physical exam
- complete blood count (CBC) within the normal reference range per the reporting clinical laboratory, established published literature and reports, or as deemed acceptable by the medical team based on the age and condition of the volunteer consistent with established clinical standards.
- The ability of the participant to understand and the willingness to sign a written consent document.
Who cannot join
- Active illnesses, immunodeficiency, history of opportunistic infection, autoimmune disease, history of or active malignancy, prior organ, bone marrow, or peripheral blood stem cell transplant or antibiotic treatment within 3 months before study intervention(s).
- Note: participants with non-melanoma skin cancer or carcinoma in situ of the cervix or breast are eligible.
- Current immunosuppressive medication.
- Any one of the following symptoms as declared by the participant at least one day per week within 3 months before study intervention(s) (Rome IV criteria [36])
- Diarrhea characterized as frequent (>2) loose stools
- Constipation defined as < 3 spontaneous bowel movements per week
Show all 11Show fewer
- Bloating and/or distention
- Abdominal pain.
- Participants with a history of the human immunodeficiency virus (HIV), hepatitis C (HCV), or hepatitis B (HBV) as confirmed by a seropositive blood test.
- Pregnancy confirmed with beta-Human Chorionic Gonadotropin (Beta-HCG) serum or urine pregnancy test performed in women of childbearing potential at screening.
- Breastfeeding participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Background:
Myelodysplastic syndromes (MDS) are disorders of blood stem cells that can develop into blood cancers. Treatment options are limited. To find better treatments, researchers need to better understand how MDS develops. To do that, they must be able to compare biospecimens from people with the disease to those of healthy people.
Read more
Objective:
This study will create a database of biospecimens collected from healthy volunteers.
Eligibility:
Healthy people aged 18 and older.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests.
Up to 5 types of samples will be collected on 1 or more days within 1 month of screening:
Blood: Blood will be drawn by inserting a needle into a vein.
Saliva: Participants will scrape the insides of their cheeks with a brush.
Stool: Participants will be given a container to collect stool at home. They will use a prepaid envelope to mail in the sample.
Bone marrow: A sample of the soft tissue inside the bones will be drawn out. The area to be biopsied, usually the lower back, will be numbed. A needle will be inserted through a small cut to remove the sample. Participants' pain will be monitored; additional numbing medicine may be used.
Skin: A piece of skin about 1/6 of an inch across will be cut away. Stitches may be used to close the wound. Participants will return to the clinic to have the stitches removed.
Participants do not have to provide all of the samples listed. They will give each sample only once.
Read the detailed description
Background:
- Myelodysplastic syndromes (MDS) are heterogeneous stem cell disorders characterized by ineffective hematopoiesis resulting in cellular dysplasia, peripheral cytopenias, and increased risk for transformation to acute myeloid leukemia (AML).
- There are limited treatment options, all of which have unimpressive response rates and limited response durations, with the only potential cure being hematopoietic stem cell transplant (HSCT). Unfortunately, as a disease of the elderly (average age of diagnosis >65 years), most participants are not eligible for HSCT due to advanced age and other comorbidities.
- It is critical we further elucidate the processes that lead to disease manifestation to develop novel therapeutic strategies and alter the natural history of the disease.
- In order to understand the biology of the disease, it is critical to have control biospecimens from healthy individuals to delineate the mechanisms driving disease pathogenesis.
Objective:
-To create a database of analyzed biospecimens collected from healthy volunteers.
Eligibility:
- Age >= 18 years old
- Healthy volunteers as confirmed by clinical evaluation
Design:
- This is a trial to analyze samples from healthy volunteers collected at NIH Clinical Center. --Participants = will be asked to provide blood, and/or bone marrow, and other samples (skin biopsy samples, saliva, stool samples).
- The total protocol accrual goal is 1,000 participants. Enrollment is expected to take place over approximately 20-50 years.
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Hematopoietic Stem Cell Malignancies, Acute Myeloid Leukemia, DNA methyltransferase inhibitors, Treatment-Related Complications, Cytotoxic Therapy, Natural History
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Healthy volunteers who will donate blood, and/or bone marrow and may donate other samples | |
| Cohort 2 | Healthy volunteers who will donate stool samples only |
What is being measured
The primary outcome is the main question the study is designed to answer.
create a database of analyzed biospecimens
Collection of biospecimens from healthy volunteers.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start11 Jan 2023
- Primary completion1 Dec 2052 (estimated)
- Study completion1 Dec 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathy L McGraw, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588154
- Sponsor's protocol ID
- 10000975
- Other IDs
- 000975-C
- Status last verified
- 13 Oct 2026
- First submitted
- 19 Oct 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All large scale genomic sequencing data will be shared with subscribers to dbGaP.@@@@@@@@@@@@All collected IPD will be shared via request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT05588154
- Acronym / sponsor ID
- 10000975
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Hematopoietic Stem Cell Malignancies, Acute Myeloid Leukemia, DNA methyltransferase inhibitors, Treatment-Related Complications, Cytotoxic Therapy, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 1 Dec 2052 (estimated)
- Study completion
- 1 Dec 2052 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Myelodysplastic syndromes (MDS) are disorders of blood stem cells that can develop into blood cancers. Treatment options are limited. To find better treatments, researchers need to better understand how MDS develops. To do that, they must be able to compare biospecimens from people with the disease to those of healthy people.
Objective:
This study will create a database of biospecimens collected from healthy volunteers.
Eligibility:
Healthy people aged 18 and older.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests.
Up to 5 types of samples will be collected on 1 or more days within 1 month of screening:
Blood: Blood will be drawn by inserting a needle into a vein.
Saliva: Participants will scrape the insides of their cheeks with a brush.
Stool: Participants will be given a container to collect stool at home. They will use a prepaid envelope to mail in the sample.
Bone marrow: A sample of the soft tissue inside the bones will be drawn out. The area to be biopsied, usually the lower back, will be numbed. A needle will be inserted through a small cut to remove the sample. Participants' pain will be monitored; additional numbing medicine may be used.
Skin: A piece of skin about 1/6 of an inch across will be cut away. Stitches may be used to close the wound. Participants will return to the clinic to have the stitches removed.
Participants do not have to provide all of the samples listed. They will give each sample only once.
Detailed description
Background:
- Myelodysplastic syndromes (MDS) are heterogeneous stem cell disorders characterized by ineffective hematopoiesis resulting in cellular dysplasia, peripheral cytopenias, and increased risk for transformation to acute myeloid leukemia (AML).
- There are limited treatment options, all of which have unimpressive response rates and limited response durations, with the only potential cure being hematopoietic stem cell transplant (HSCT). Unfortunately, as a disease of the elderly (average age of diagnosis >65 years), most participants are not eligible for HSCT due to advanced age and other comorbidities.
- It is critical we further elucidate the processes that lead to disease manifestation to develop novel therapeutic strategies and alter the natural history of the disease.
- In order to understand the biology of the disease, it is critical to have control biospecimens from healthy individuals to delineate the mechanisms driving disease pathogenesis.
Objective:
-To create a database of analyzed biospecimens collected from healthy volunteers.
Eligibility:
- Age >= 18 years old
- Healthy volunteers as confirmed by clinical evaluation
Design:
- This is a trial to analyze samples from healthy volunteers collected at NIH Clinical Center. --Participants = will be asked to provide blood, and/or bone marrow, and other samples (skin biopsy samples, saliva, stool samples).
- The total protocol accrual goal is 1,000 participants. Enrollment is expected to take place over approximately 20-50 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Healthy volunteers who will donate blood, and/or bone marrow and may donate other samples |
| Cohort 2 | – | –Healthy volunteers who will donate stool samples only |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are healthy volunteers, selected from the general population. Employees may also volunteer per the protocol.
Key inclusion criteria (6 listed)
- Age >= 18 years old
- Healthy volunteers; the following confirmed by the Principal Investigator or designees based on recent (within 3 months before study intervention(s))
- medical history
- physical exam
- complete blood count (CBC) within the normal reference range per the reporting clinical laboratory, established published literature and reports, or as deemed acceptable by the medical team based on the age and condition of the volunteer consistent with established clinical standards.
Key exclusion criteria (11 listed)
- Active illnesses, immunodeficiency, history of opportunistic infection, autoimmune disease, history of or active malignancy, prior organ, bone marrow, or peripheral blood stem cell transplant or antibiotic treatment within 3 months before study intervention(s).
- Note: participants with non-melanoma skin cancer or carcinoma in situ of the cervix or breast are eligible.
- Current immunosuppressive medication.
- Any one of the following symptoms as declared by the participant at least one day per week within 3 months before study intervention(s) (Rome IV criteria [36])
- Diarrhea characterized as frequent (>2) loose stools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
create a database of analyzed biospecimens
Time frame: ongoing
Collection of biospecimens from healthy volunteers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All large scale genomic sequencing data will be shared with subscribers to dbGaP.@@@@@@@@@@@@All collected IPD will be shared via request to the principal investigator.
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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathy L McGraw, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle F Pinkiert, R.N. ((240) 858-7566, danielle.pinkiert@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
create a database of analyzed biospecimens (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.