Collecting samples from healthy volunteers for analysis of blood disorders
Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies
This study is trying to collect samples from healthy volunteers to help researchers learn more about blood disorders like myelodysplastic syndromes and their progression to leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05588154 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive database of biospecimens from healthy volunteers to better understand myelodysplastic syndromes (MDS) and their progression to acute myeloid leukemia (AML). Participants aged 18 and older will undergo screening and provide various samples, including blood, bone marrow, saliva, stool, and skin biopsies. The goal is to compare these samples with those from individuals with MDS to elucidate disease mechanisms and develop novel therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18 and older.
Not a fit: Patients with active illnesses, immunodeficiencies, or a history of malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with myelodysplastic syndromes.
How similar studies have performed: While this approach is critical for understanding MDS, similar studies have shown success in utilizing healthy biospecimens for comparative analysis in other hematological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kathy L McGraw, Ph.D. — National Cancer Institute (NCI)
- Study coordinator: Ashley E Carpenter
- Email: carpentera@mail.nih.gov
- Phone: (240) 550-0492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.