Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers (NCT00442195) | Clinical Trial Compass
RecruitingNot Applicable
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
United States1,000 participantsStarted 2007-03-03
Plain-language summary
The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia.
Healthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows:
* Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein.
* Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.
* Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.
Who can participate
Age range
8 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Self-declared healthy volunteer (for blood and buccal mucosa sample donors).
Be healthy, as determined by Principal Investigator or designee based on recent (\<3 months) history, physical and laboratory results (for bone marrow and skin tissue sample donors).
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Age 8 years and older (no upper limit) for blood and buccal mucosa sampling.
OR
Ages 18 years or older (no upper limit) for bone marrow or skin tissue sampling.
EXCLUSION CRITERIA:
Unable to comprehend the investigational nature of the protocol participation.
CBC determined outside expected normal ranges for the subject (bone marrow and skin tissue donors only).
Pregnancy
Age less than 18 years for skin tissue sampling, bone marrow aspirate and biopsy.
Off campus volunteers for skin tissue sampling bone marrow aspirate and biopsy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To obtain blood, bone marrow, and skin punch biopsy samples and/or buccal mucosa samples from subjects seeking to participate as healthy volunteers in NIH laboratory research studies.
Timeframe: Ongoing
Trial details
NCT IDNCT00442195
SponsorNational Heart, Lung, and Blood Institute (NHLBI)