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Cooperative Assessment of Late Effects for SCD Curative Therapies

Study acronym: COALESCE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 2026 → Nov 2026
See other at-risk trials from Vanderbilt University Medical Center

Record History

  1. Primary endpoints: details revised at 2 of 9 entries Enrollment closed, study ongoing · Final enrollment: 377 participants (planned 750) · Study description revised · 3 more Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 377 participants (planned 750)
    • Study description revised
    • Site details revised at 5 of 5 sites
    • Collaborators: details revised at 2 of 5 entries
    • Eligibility criteria expanded, about 4 words
  2. Primary completion pushed from Jun 2026 to Nov 2026v10
  3. Primary completion date: Dec 2025 to Jun 2026 Completion date: Feb 2026 to Feb 2027v9 Show 1 more changeShow less
    • Completion date: Feb 2026 to Feb 2027
  4. Re-verified, no change to tracked fieldsv8
  5. Collaborators: 3 to 5v7 See this version in full on ClinicalTrials.gov ↗
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 29, 2022 to Jul 12, 2022 · Site details revised at 5 of 5 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Jul 29, 2022 to Jul 12, 2022
    • Site details revised at 5 of 5 sites
  3. Start date: Jun 17, 2022 to Jul 29, 2022v4
  4. Start date: May 2022 to Jun 17, 2022v3
  5. Start date: Mar 2022 to May 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sickle Cell Disease is one of the most common genetic diseases in the United States, occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed with SCD in the United States. Mortality for children with SCD has decreased substantially over the past 4 decades, with \>99% of those born in high resource settings, including the United States, France, and England, now surviving to 18 years of age. However, the life expectancy of adults with SCD is severely shortened. Dysfunction of the heart, lung, and kidney is directly associated with decreased life expectancy. With the variety of curative therapies that are now available for SCD, long-term health outcomes studies are time-sensitive. As of now, efforts to determine long-term health outcomes following curative therapies for SCD have been limited. Though curative therapies initially should provide a cure for symptoms of SCD, there is the risk of late health outcomes to consider. Defining health outcomes following curative therapy is essential to improve personalized decision-making when considering curative versus disease-modifying therapeutic options. The primary goal of this study is to determine whether curative therapies for individuals with SCD will result in improved or worsening heart, lung, and kidney damage when compared to individuals with SCD receiving standard therapy. The investigators will also explore whether certain genes are associated with a good or bad outcome after curative therapy for SCD.
Trial Details
NCT Number NCT05153967
Lead Sponsor Vanderbilt University Medical Center
Collaborators: Johns Hopkins University, Children's National Research Institute, Emory University, University of Illinois at Chicago, Children's Healthcare of Atlanta
Conditions Sickle Cell Disease, Pulmonary Disease, Renal Disease, Heart Disease
Enrollment 377 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov