RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-25
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03937817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged 18-70 years.
  2. 2. Able to provide informed consent.
  3. 3. Willing to allow biological samples to be stored for future research.
  4. 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. 5. Willing to allow genetic testing on collected biological samples.
  1. * Exclusion Criteria for All Participants
  2. 1. Pregnancy.
  3. 2. Positive testing for hepatitis B virus, hepatitis C virus, or HIV (as determined by serum screening tests or relevant viral quantitative studies.)
  4. 3. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
  5. 4. Any condition that, in the opinion of the PI, contraindicates participation in this study.
  6. * Additional Exclusion Criteria for Individuals Giving Blood for Research
  7. 1. Currently taking anticoagulation medication.
  8. 2. Platelets \< 100,000/microL.
  9. 3. History of keloid formation (or irregular fibrous tissue formed at the site of a scar or injury).
  10. 4. History of adverse reactions to lidocaine or other local anesthetics.
  11. 5. Any condition that, in the opinion of the PI, contraindicates this procedure.
  12. 1. Prothrombin time (PT) \> 1 second above the upper limit of normal (ULN) or international normalized ratio \> 1.3.
  13. 2. Partial thromboplastin time (PTT) \> 1 second above ULN.
  14. 3. Platelets \< 150,000/microL.
  15. 4. Currently taking anticoagulation medication.
  16. 5. Use of aspirin within 2 weeks of the bronchoscopy or NSAIDs within 2 days of the bronchoscopy.
  17. 6. Diagnosis of a pulmonary disorder (eg, asthma, chronic bronchitis, cystic fibrosis, or bronchiectasis).
  18. 7. Respiratory tract infection within the last 4 weeks.
  19. 8. History of adverse reactions to systemic and/or local anesthetics that will be used for this procedure.
  20. 9. History of cigarette smoking within the past 3 months.
  21. 10. History of chronic opioid use.
  22. 11. History of drug or alcohol abuse.
  23. 12. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 40% of predicted or pre-bronchodilator FEV1 \< 35% of predicted.
  24. 13. Active bronchospasm on physical examination.
  25. 14. History of lidocaine allergy.
  26. 15. Any condition that, in the opinion of the PI, contraindicates this procedure.

Contacts and Locations

Study Contact

Mary J Jackson, R.N.
CONTACT
(301) 761-5667
alpha.study@nih.gov
Hans C Ackerman, M.D.
CONTACT
(301) 761-5646
hans.ackerman@nih.gov

Principal Investigator

Hans C Ackerman, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Hans C Ackerman, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-25
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2019-09-25
Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Alpha and Beta Thalassemia
  • Sickle Cell Disease
  • Malaria
  • Human Physiology