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Massive sickle cell study aims to unlock secrets of organ damage

NCT ID NCT02098863

Knowledge-focused Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 10,000 people with sickle cell disease for many years, tracking their health during regular clinic visits. Researchers want to learn how the disease damages organs over time and how treatments like hydroxyurea might help prevent that damage. A smaller part of the study will also look at how genes affect response to hydroxyurea.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how to prevent long-term organ damage in sickle cell disease and identify who benefits most from hydroxyurea.
What could go wrong
This is an observational study, not a treatment trial. It collects data over many years, so results will take time and may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2014

Expected to finish

Dec 2044

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with a diagnosis of sickle cell disease of any genotype.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

SCCRIP Inclusion Criteria: * A diagnosis of sickle cell disease of any genotype. * PK Sub-study Inclusion Criteria: * Participants at St. Jude Children's Research Hospital who are consented to the parent protocol (SCCRIP, Amendment 6.1 or above). * Participants currently completing a hydroxyurea (HU) regimen, who have achieved maximum tolerated dose and have maintained that dose for a minimum of 90 days prior to enrollment. SCCRIP Exclusion Criteria: * Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised. * PK Sub-study Exclusion Criteria: * Participants unable to complete the blood draws required for PK sampling. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Children's Hospital of Illinois at OSF-Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Methodist Adult Comprehensive Sickle Cell Center

    RECRUITING

    Memphis, Tennessee, 38104, United States

  • Novant Health Hemby Children's Hospital

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Our Lady of the Lake Regional Medical Center

    COMPLETED

    Baton Rouge, Louisiana, 70808, United States

  • Regional One Health, Diggs-Kraus Sickle Cell Center

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

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