Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research

Recruiting

• Conditions: Healthy Volunteers; Inflammation in Cardiopulmonary and Vascular Disease States; Endothelial Dysfunction

• Registration Number: NCT03253705
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief 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 Blood will be withdrawn into multiple syringes or tubes.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...

Detailed Description

Our department is evaluating various aspects of the cardiovascular system and/or endothelial dysfunction and/or inflammation in disease states, such as, but not limited to, pulmonary hypertension (PH) and other pulmonary vascular diseases, arteriosclerosis, transplantation, inflammatory processes and sepsis. The collection of human blood and urine from both research subjects and healthy volunteers is necessary for the development of relevant laboratory assays and protocols, and to further research studies requiring such evaluations. In research subjects undergoing renal replacement therapy who produce limited urine we may also sample ultrafiltrate as a surrogate for urine. This protocol defines in general terms the purposes for which blood, urine and ultrafiltrate will be collected by members of the NIH s Clinical Center (CC), Critical Care Medicine Department (CCMD) and collaborating institutions and establishes general conditions under which sampling will be performed.

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-18
• Study Start: 2017-09-14
• Status Verified: 2025-05-07
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exploratory assay development	10 years	Development of new assays

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States