RecruitingNot Applicable

Natural History of Sickle Cell Disease

United States3,500 participantsStarted 2004-04-29

Plain-language summary

This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. Subjects will receive their general medical care outside the NIH and will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for multiple visits. Subjects may be asked to return for additional testing as needed. Clinical care for patients with sickle cell disease will be provided as appropriate through the Sickle Cell Clinic and the inpatient clinical center.

Who can participate

Age range

2 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a natural history study rather than a treatment trial, what does participation actually involve for me day-to-day, and would I still be able to receive standard sickle cell treatments including for pain crises while enrolled?
2This study is specifically focused on minority and ethnic patients with sickle cell disease — can you help me understand how the data collected here might eventually benefit communities like mine, and how that weighs against any time or logistical demands of joining?
3Because this trial is in the 'NA' phase and is focused on observation rather than testing a new therapy, does it carry any different risks compared to my usual care, or is the main commitment simply sharing my medical information and experiences?
4The study lists pain crisis as a key condition it's tracking — how would my pain crisis history and frequency be documented, and could participating in any way affect how my pain episodes are managed or treated?
5Are there standard-of-care options or other studies I should consider alongside or instead of this observational study, given that it isn't testing a new treatment but rather gathering long-term data on how sickle cell disease progresses?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To gather, through clinical experience, information regarding the natural history, co-morbid conditions and outcomes, and complications relating to sickle cell disease and other hemolytic disorders in minority/ethnic patients

Timeframe: ongoing

Trial details

NCT IDNCT00081523

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Contact for this trial

Nancy A Asomaning

(301) 605-0398 nancy.asomaning@nih.gov

View on ClinicalTrials.gov More Pain Crisis trials