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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying myelodysplastic syndromes (MDS), which are disorders that affect blood stem cells and can lead to blood cancers. The goal of this study is to collect samples from healthy volunteers, like blood, saliva, stool, bone marrow, and skin, to help researchers better understand MDS and find improved treatments for those affected by it. By comparing these samples from healthy individuals to those of patients with MDS, researchers hope to gain valuable insights into how this condition develops.

To participate, you need to be a healthy adult aged 18 or older. You will go through a screening process, which includes a physical exam and some lab tests. If eligible, you will be asked to provide one or more samples, but you don’t have to give all five types. The sampling process is straightforward: blood will be drawn from your arm, saliva will be collected by brushing the inside of your cheeks, stool will be collected at home, and bone marrow and skin samples will be taken in a clinic with local anesthesia to minimize discomfort. Remember, your participation can help advance research in a vital area of healthcare!

Gender

ALL

Eligibility criteria

• * 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.