Collection of Blood, Bone Marrow, Skin, Saliva, and Stool Samples From Healthy Volunteers Used for Comparative Analysis of Myeloid Malignancies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 120 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Urine samples, Physical exams, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "They will have a physical exam with blood and urine tests."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study collects samples from healthy adults age 18 and older to compare with samples from people with blood disorders called myelodysplastic syndromes (MDS). MDS can turn into blood cancer. Volunteers may give blood, bone marrow, skin, saliva, or stool samples, but do not have to give every type.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- The study team confirms you are healthy based on your health history and a physical exam within the past 3 months.
- Your blood cell counts are normal or acceptable to the study team.
- You can understand the study and are willing to sign a consent form.
Who can't join
- You have an active illness, a weak immune system, an illness where your immune system attacks your body, or a past infection linked to weak immune defenses.
- You have or have had cancer. Exceptions are non-melanoma skin cancer and carcinoma in situ of the cervix or breast—abnormal cells that have not spread into nearby tissue.
- You have had an organ, bone marrow, or blood stem cell transplant.
- You took antibiotics within 3 months before giving samples.
- You currently take medicine that weakens your immune system.
- Within the past 3 months, you had belly pain, bloating, belly swelling, or frequent loose stools (more than 2) at least 1 day a week, or constipation (fewer than 3 bowel movements a week without help).
- You have a history of HIV, hepatitis B, or hepatitis C confirmed by a blood test.
- You are pregnant, as confirmed by a screening test, or are breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda