Recruiting

Biospecimen Collection

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05588154

Conditions

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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. 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.

Conditions

Myelodysplastic Syndromes

Study ID

NCT05588154

Start date

Jan 11, 2023

Status verified date

Jul 21, 2026

Completion date

Dec 1, 2052

Anticipated

Primary completion date

Dec 1, 2052

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • 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.

EXCLUSION CRITERIA:

\- 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
  • 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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • create a database of analyzed biospecimens [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Danielle F Pinkiert, R.N.

(240) 858-7566danielle.pinkiert@nih.gov

Kathy L McGraw, Ph.D.

(240) 760-7134kathy.mcgraw@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Jul 23, 2026

Last verified

Jul 21, 2026

Keywords

  • Hematopoietic Stem Cell Malignancies
  • Acute Myeloid Leukemia
  • DNA methyltransferase inhibitors
  • Treatment-Related Complications
  • Cytotoxic Therapy
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-07-23.