Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies

NCT05588154 | Recruiting

• 2 other identifiers: 10000975000975-C
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• create a database of analyzed biospecimens

  Collection of biospecimens from healthy volunteers.

  ongoing

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are healthy volunteers, selected from the general population. Employees may also volunteer per the protocol.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Kathy L McGraw, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley E Carpenter

CONTACT

(240) 550-0492; carpentera@mail.nih.gov

Kathy L McGraw, Ph.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 20, 2022
• Study Start: January 11, 2023
• Primary Completion (Estimated): December 1, 2052
• Study Completion (Estimated): December 1, 2052
• Last Updated: May 8, 2026

Record last verified: 2026-05-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.@@@@@@@@@@@@Non genomic clinical data will be shared 10 years after the primary objective has been attained
• Access Criteria: Genomic data are made available via dbGaP through requests to the data custodians.@@@@@@@@@@@@The principal investigator will review IPD requests.

Locations

US (1)