Recruiting

Studies of the Natural History of Sickle Cell Disease

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Anemia
+14

+ Anemia, Hemolytic
+ Anemia, Hemolytic, Congenital
From 2 to 90 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: April 2004
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactNancy A Asomaning
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 29, 2004Actual date on which the first participant was enrolled.

This protocol will permit the establishment of a repository of biospecimens from individuals affected with sickle cell disease to identify and evaluate underlying disease mechanism(s), and to facilitate understanding of the pathogenesis and natural history of vaso-occlusive painful crisis and other complications of the disease. Patients will be evaluated with a medical history and physical examination and routine laboratory studies will be obtained as needed to assess diagnosis, disease activity, and disease complications and to monitor for treatment-related responses and toxicities. This protocol may also provide for the continued storage and analysis of clinical and research data, and biospecimens previously obtained from other NIH Institutional Review Board (IRB)-approved protocols with subject consent. Patients eligible for other research protocols will be offered an opportunity to participate in these studies after signed informed consent has been obtained. Apart from such protocols, any medical care or additional tests/investigations recommended or provided to the patient will be consistent with routine standards of practice and will be provided in consultation with the patient s referring physician.

Official TitleStudies of the Natural History of Sickle Cell Disease 
NCT00081523
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactNancy A Asomaning
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
3500 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 2 to 90 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Anemia, Sickle Cell
Cardiovascular Diseases
Hematologic Diseases
Hemic and Lymphatic Diseases
Hemoglobinopathies
Hypertension
Hypertension, Pulmonary
Lung Diseases
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Respiration Disorders
Respiratory Tract Diseases
Vascular Diseases
Genetic Diseases, Inborn
Acute Chest Syndrome
Criteria

* INCLUSION CRITERIA: * Individuals with known or suspected sickle cell disease * 2 years of age and older * Willing to provide informed consent or appropriate informed consent from parent or legal guardian * Patients seen at sickle outpatient clinics at any one of the participating centers (CNHS or NIH). EXCLUSION CRITERIA: * Patient and/or guardian unable and unwilling to give informed consent or assent. * Patients less than 2 years of age. Individuals with known or suspected sickle cell disease will meet the inclusion criteria to enroll in this protocol and can undergo study activities. However, if the individual is found not to have sickle cell disease after enrollment, they will be removed from the protocol, and their research samples will be discarded but they will be counted toward the study accrual. The study team will notify the individual about their removal from the study and explain the reason for it. Any necessary regulatory reporting will also be completed.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Better characterization of the natural history of sickle cell disease

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Recruiting
Childrens National Health CenterWashington D.C., United StatesSee the location
Recruiting
National Institutes of Health Clinical CenterBethesda, United States
Completed
Suburban HospitalBethesda, United States

Recruiting
3 Study Centers
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