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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Urine samples, Physical exams, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will be screened with a medical history, physical exam, and blood and urine tests."
  • "They will give them over 5 years."
  • "These participants will also have a physical exam, chest x-ray, and heart tests after the procedure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects body samples to help researchers learn about blood disorders. It is for adults ages 18–70 with blood disorders and healthy volunteers. Samples may be collected over 5 years, and participants can choose which samples to give.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–70 years old, with or without a blood disorder.
  • Be able to understand the study and agree to take part.
  • Agree to have samples stored for future research.
  • Be willing to give at least one type of sample, such as saliva, urine, blood, fat, or lung mucus and cells.
  • Agree to genetic testing on the samples.

Who can't join

  • For anyone giving samples in person at the NIH Clinical Center: pregnancy, a positive hepatitis B, hepatitis C, or HIV test, or a health condition that needs care to prevent serious harm or makes the study unsafe.
  • For blood samples: low hemoglobin, the protein that carries oxygen in blood. Limits are below 10 g/dL for healthy women, 12 g/dL for healthy men, or 6 g/dL for people with sickle cell disease or other long-term anemia.
  • For fat samples: taking blood thinners; platelets below 100,000/microL (cells that help blood clot); past thick, raised scars; reactions to numbing drugs; or another condition that makes the procedure unsafe.
  • For lung samples: blood clotting tests outside the study limits, platelets below 150,000/microL, or taking blood thinners. Aspirin within 2 weeks or anti-inflammatory pain drugs called NSAIDs within 2 days also rule out this procedure.
  • For lung samples: a lung disease, a breathing tract infection within 4 weeks, very low breathing test results, or tightened airways during the exam.
  • For lung samples: smoking cigarettes within 3 months, a history of long-term opioid use, or a history of drug or alcohol abuse.
  • For lung samples: an allergy to lidocaine, past reactions to drugs used to numb you or keep you comfortable during the procedure, or another condition that makes the procedure unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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 sites (1)

MD