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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Rebecca B Alexander
rebecca.alexander@nih.gov
(240) 781-4037
Backup
Kathy L McGraw, Ph.D.
kathy.mcgraw@nih.gov
(240) 760-7134
Time Frame
Start Date: 2023-01-11
Estimated Completion Date: 2052-12-01
Participants
Target number of participants: 1000
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov