Sickle Cell DiseaseNCT00047996
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
An observational study of Sickle Cell Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial summary
The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 2,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2002to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal subjects, Male/Female
Who may be able to join
- Males or females of age 18 years and older can be included in the study.
Who cannot join
- Individuals without sickle cell disease or other chronic anemias who wish to donate blood will be excluded if the hemoglobin is less than 10 g/dL for women or less than 12g/dL for men.
- Individuals with sickle cell disease or other chronic anemias will be excluded from donating blood samples if the hemoglobin is less than 6 g/dL.
- A participant s most recent CBC result, obtained in the past 12 months, will be used to determine eligibility.
- There are no exclusion criteria for participants donating urine.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
INOVA Fairfax Hosptial
Fairfax, Virginia, 22042
About this study
Official title: Human Specimen Collection to Support Basic and Clinical Research
The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed....
Read the detailed description
The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed.
- Conditions
- Sickle Cell Disease
- Keywords
- DNA, Endothelial Function, Leukocyte Gene Expression, RNA, Natural History, Sickle Cell, Coronary Artery Disease, CAD, Healthy Volunteer, HV
- Medical subject headings
- Anemia, Sickle Cell, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Clinical Center Patients, Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluating the role of nitric oxide, inflammatory mediators, and endothelial function in inflammatory diseases of the vasculature such as sickle cell disease, coronary artery disease, pulmonary vascular or advanced lung disease, malaria, and sep...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2002 (estimated)
- Study start4 Nov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Swee Lay Thein, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047996
- Sponsor's protocol ID
- 030015
- Other IDs
- 03-H-0015
- Status last verified
- 19 Oct 2026
- First submitted
- 11 Jul 2006
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tumburu L, Ghosh-Choudhary S, Seifuddin FT, Barbu EA, Yang S, Ahmad MM, Wilkins LHW, Tunc I, Sivakumar I, Nichols JS, Dagur PK, Yang S, Almeida LEF, Quezado ZMN, Combs CA, Lindberg E, Bleck CKE, Zhu J, Shet AS, Chung JH, Pirooznia M, Thein SL. Circulating mitochondrial DNA is a proinflammatory DAMP in sickle cell disease. Blood. 2021 Jun 3;137(22):3116-3126. doi: 10.1182/blood.2020009063.
PubMed 33661274