RECRUITING

Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling

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: Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant. Objective: To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant. Eligibility: People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream. Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected....

Official Title

Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling

Quick Facts

Study Start:2024-05-17
Study Completion:2029-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06313398

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 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, aged 18 years or greater with confirmed diagnosis of SCD (all genotypes), thalassemia (beta and/or alpha), or other inherited hemoglobinopathy not otherwise specified.
  4. 4. Be at steady state for their underlying disease (e.g. SCD or thalassemia) or post-bone marrow transplantation status, as evidenced by medical history.
  5. 5. Ability to have blood samples drawn.
  6. 6. For female participants of child-bearing potential, agree to use birth control during study participation. Female subjects of child-bearing potential must agree to use a medically acceptable method of birth control such as an oral contraceptive, intrauterine device, barrier and spermicide, or contraceptive implant/injection from start of screening through 4 months after infusion.
  7. 7. Agreement to adhere to Lifestyle Considerations throughout study duration
  1. 1. Consumption of biotin supplements or raw eggs within the last 30 days.
  2. 2. Blood loss within the previous 8 weeks (\>540 mL).
  3. 3. Treatment with chronic transfusion therapy for their underlying SCD and/or thalassemia.
  4. 4. Patients on hemodialysis, due to possibility of early removal of biotinylated RBCs.
  5. 5. Pregnancy, lactation or absence of adequate contraception for fertile female subjects.
  6. 6. Pediatric subjects will not participate in this study.
  7. 7. Known allergic reactions to biotin, due to risk of possible life-threatening allergic reaction.
  8. 8. Current diagnosis of malignancy (liquid and/or solid).

Contacts and Locations

Study Contact

Christina C Luckett
CONTACT
(301) 529-7863
christina.luckett@nih.gov
John F Tisdale, M.D.
CONTACT
(301) 402-6497
johntis@mail.nih.gov

Principal Investigator

John F Tisdale, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • John F Tisdale, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

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 Date2024-05-17
Study Completion Date2029-06-15

Study Record Updates

Study Start Date2024-05-17
Study Completion Date2029-06-15

Terms related to this study

Keywords Provided by Researchers

  • Red Cell
  • Hemoglobinopathy
  • Thalassemia
  • Sickle Cell Disease
  • Biotin

Additional Relevant MeSH Terms

  • Sickle Cell Disease
  • Thalassemia
  • Hemoglobinopathy