NCT03937817

Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants

Recruiting now Last updated 14 April 2026

What this trial tests

trial in Alpha and Beta Thalassemia in 300 participants. Currently enrolling.

Timeline

25 September 2019

Primary endpoint
31 March 2029

31 March 2029

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	300
Start date	25 September 2019
Primary completion	31 March 2029
Estimated completion	31 March 2029
Sites	1 location across United States

Conditions studied

• Alpha and Beta Thalassemia — all drugs for Alpha and Beta Thalassemia →
• Sickle Cell Disease — all drugs for Sickle Cell Disease →
• Malaria — all drugs for Malaria →
• Human Physiology — all drugs for Human Physiology →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 70, any sex, with Alpha and Beta Thalassemia or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Blood disorders like sickle cell disease and malaria affect many people around the world. Researchers want to learn more about blood disorders. To do this, they need to collect biological samples from people with blood disorders. They also need to collect samples from healthy people.

Objective:

To collect samples to use for research on blood disorders.

Eligibility:

People ages 18-70 who have blood disorders. Healthy volunteers without blood disorders are also needed.

Design:

Participants will be screened with a medical history, physical exam, and blood and urine tests.

Participants will give one or more samples. They will give them over 5 years. They can choose not to give any of the samples:

Saliva: Participants will spit into a tube. They may also have the inside of their mouth swabbed.

Urine: Participants will urinate into a cup.

Blood and blood waste products: Blood will be taken through a needle in the participant s arm.

Fat samples: An area on the participant s belly or buttock will be numbed. A small cut will be made into the skin and a small piece of fat removed.

Mucus and cells from the lungs: The participant will be sedated. A flexible tube will be inserted through the nose or mouth into the lung airways. These participants will also have a physical exam, chest x-ray, and heart tests after the procedure.

...

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sickle Trait and Alpha Thalassemia Increase NOS-Dependent Vasodilation of Human Arteries Through Disruption of Endothelial Hemoglobin-eNOS Interactions.
   Brooks SD, Ruhl AP, Zeng X, Cruz P, et al · · 2025 · cited 3× · PMID 39633569 · DOI 10.1161/circulationaha.123.066003
2. Magnitude and variability of blood pressure and renal vascular conductance responses to postural changes, exercise, and cold in black adults: A pilot study.
   Ibrahim MH, McLure AJ, Jackson MJ, Harrison B, et al · · 2026 · PMID 42087563 · DOI 10.14814/phy2.70888