Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research (NCT03253705) | Clinical Trial Compass
RecruitingNot Applicable
Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research
United States1,000 participantsStarted 2017-09-14
Plain-language summary
Background:
This study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood or urine. Blood samples may also be collected to make special cells. These are called induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be converted into any type of cell. Researchers want to study in the lab iPSCs that are derived from blood samples.
Objective:
To collect samples to help study genes, proteins, sugars, fats, vitamins, and other metabolites found in blood or urine.
Eligibility:
Healthy volunteers and patients ages 18 and older
Design:
First-time research study participants at NIH will have an initial visit for this study that should last no more than 1 hour. All other visits should last 20 30 minutes.
Participants will undergo a limited history and physical exam.
Participants may have routine blood and urine tests.
If participants are giving a blood sample, they must have a hemoglobin level checked in the past 12 months to make sure it is safe for them to give a blood sample for research.
Participants may have a venous blood collection. They may do this at several visits. They will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or tubes.
Participants may be asked to provide urine in an appropriate container...
Who can participate
Age range
18 Years – 100 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
. Males or females of age greater than or equal to 18 years old.
. Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)
Exclusion criteria
. Hemoglobin \<7.0 g/dL
. Currently receiving infusion of epinephrine; or dopamine at an infusion rate of \>2.5 microgram/kg/min, norepinephrine of \> 20mcg/min, or vasopressin \> 0.04 units/min\*
. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \<90 mmHg. In the absence of known CAD a SBP \<80 mmHg or mean arterial pressure (MAP) \<60 mmHg with or without vasopressors\*.
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
Exploratory assay development
Timeframe: 10 years
Trial details
NCT IDNCT03253705
SponsorNational Institutes of Health Clinical Center (CC)
. Males or females of age greater than or equal to 18 years old.
. Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)
. Hemoglobin \<7.0 g/dL
. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \<90 mmHg. In the absence of known CAD a SBP \<80 mmHg or mean arterial pressure (MAP) \<60 mmHg.
. Males or females of age greater than or equal to 18 years old