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

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.

• 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.