Recruiting

Biospecimen Collection

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT03937817

Conditions

Alpha and Beta Thalassemia

Sickle Cell Disease

Malaria

Human Physiology

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Alpha and Beta Thalassemia

Sickle Cell Disease

Malaria

Human Physiology

Study ID

NCT03937817

Start date

Sep 25, 2019

Status verified date

Aug 19, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

  • PARTICIPANT INCLUSION CRITERIA:

1. Aged 18-70 years.
2. Able to provide informed consent.
3. Willing to allow biological samples to be stored for future research.
4. Willing to provide one or more of the following tissues: saliva, urine, blood, blood waste products, adipose tissue, bronchial brushing, and/or BAL samples.
5. Willing to allow genetic testing on collected biological samples.

PARTICIPANT EXCLUSION CRITERIA:
  • Exclusion Criteria for All Participants

The following exclusion criteria apply to all participants who will provide any of the following samples in-person at the NIH CC: saliva, urine, blood, blood waste products, adipose tissue, bronchial brushing, and/or BAL samples:

1. Pregnancy.
2. Positive testing for hepatitis B virus, hepatitis C virus, or HIV (as determined by serum screening tests or relevant viral quantitative studies.)
3. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
4. Any condition that, in the opinion of the PI, contraindicates participation in this study.

  • Additional Exclusion Criteria for Individuals Giving Blood for Research

1\. Hemoglobin < 10 g/dL for healthy female volunteers, < 12 g/dL for healthy male volunteers, or < 6 g/dL for participants with sickle cell disease or other chronic anemias.

-Additional Exclusion Criteria for Adipose Tissue Biopsy

Individuals meeting any of the following criteria will be excluded from undergoing adipose tissue biopsy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.

1. Currently taking anticoagulation medication.
2. Platelets < 100,000/microL.
3. History of keloid formation (or irregular fibrous tissue formed at the site of a scar or injury).
4. History of adverse reactions to lidocaine or other local anesthetics.
5. Any condition that, in the opinion of the PI, contraindicates this procedure.

Use of aspirin (or acetylsalicylic acid) and nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted.

-Additional Exclusion Criteria for Bronchoscopy

Individuals meeting any of the following criteria will be excluded from undergoing bronchoscopy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.

1. Prothrombin time (PT) > 1 second above the upper limit of normal (ULN) or international normalized ratio > 1.3.
2. Partial thromboplastin time (PTT) > 1 second above ULN.
3. Platelets < 150,000/microL.
4. Currently taking anticoagulation medication.
5. Use of aspirin within 2 weeks of the bronchoscopy or NSAIDs within 2 days of the bronchoscopy.
6. Diagnosis of a pulmonary disorder (eg, asthma, chronic bronchitis, cystic fibrosis, or bronchiectasis).
7. Respiratory tract infection within the last 4 weeks.
8. History of adverse reactions to systemic and/or local anesthetics that will be used for this procedure.
9. History of cigarette smoking within the past 3 months.
10. History of chronic opioid use.
11. History of drug or alcohol abuse.
12. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 40% of predicted or pre-bronchodilator FEV1 < 35% of predicted.
13. Active bronchospasm on physical examination.
14. History of lidocaine allergy.
15. Any condition that, in the opinion of the PI, contraindicates this procedure.

Co-enrollment guidelines: Participants may be co-enrolled in other studies. However, the PI must be notified of co-enrollment.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Healthy volunteers and patients with hematologic and hemolytic diseases, including alpha and beta globin variants, sickle cell disease, malaria, or other diseases involving inflammation or endothelial dysfunction.

Primary outcome measure

  • Collect biological specimens (saliva, urine, blood, blood waste products, adipose tissue, bronchial brushing, and/or BAL) [ Time Frame: Throughout study ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 8, 2026

Last verified

Aug 19, 2026

Keywords

  • Assay Development
  • Malaria
  • Sickle Cell Disease
  • Alpha and Beta Thalassemia
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-08.