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NCT06941389 · ClinicalTrials.gov registry record

Comparing the Effectiveness of Matched Related Donor Hematopoietic Stem Cell Transplantation to Disease Modifying Therapy in Pediatric Patients With Sickle Cell Disease

A clinical trial of Sickle Cell Disease (SCD), sponsored by University of Rochester.

Recruiting
Registry status
480
Enrollment target
20
Study locations

NCT06941389: Recruiting study of Sickle Cell Disease (SCD), sponsored by University of Rochester.

NCT06941389 is a study of Sickle Cell Disease (SCD) that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 480 participants, above the 295-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (63% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06941389, a study of Sickle Cell Disease (SCD), is actively recruiting participants, sponsored by University of Rochester.

RECRUITING
Registry status
480 participants
Enrollment target
20
Study locations

Study Summary

The WeDecide study is a large observational study comparing the long-term effects of matched related donor hematopoietic stem cell transplantation (MRD HCT) and non-transplant disease-modifying therapies (NT-DMT) for pediatric patients with sickle cell disease (SCD). The study aims to assess health-related quality of life (HRQoL), cognitive function, risks, and benefits of both treatments, including survival rates, chronic complications, and organ damage prevention. With 160 children in the MRD HCT group and 320 in the NT-DMT group, aged 3-20.9 years, the study will follow participants for three years, examining factors like disease severity, treatment history, and social determinants of health. By providing a comprehensive comparison, the study seeks to inform clinical decisions and improve understanding of SCD treatment outcomes, ultimately supporting families and healthcare providers in choosing the best treatment options.

Primary Outcome

Measures physical, emotional, social, and school functioning as reported by parents.

Conditions Studied

Sickle Cell Disease (SCD)

Study Locations (20)

New York

  • Roswell Park (MRD-HCT) - Buffalo
  • Columbia Presbytarian (NT-DMT) - New York
  • Cohen's Children Hospital (NT-DMT) - Queens
  • University of Rochester (MRD-HCT) - Rochester
  • University of Rochester (NT-DMT) - Rochester
  • Children's Hospital at Montefiore (MRD HCT) - The Bronx
  • Children's Hospital at Montefiore (NT-DMT) - The Bronx

Alabama

  • Children's of Alabama (MRD-HCT) - Birmingham
  • Children's of Alabama (NT-DMT) - Birmingham

Indiana

  • Riley Children's Hospital (MRD-HCT) - Indianapolis
  • Riley's Children Hospital (NT-DMT) - Indianapolis

Massachusetts

  • Boston Children's Hospital (MRD-HCT) - Boston
  • Boston Children's Hospital (NT-DMT) - Boston

Missouri

  • Wahington Univ in St Louis (NT-DMT) - St Louis
  • Washington University in St Louis (MRD-HCT) - St Louis

Delaware

  • Nemours Children's Hospital, Delaware (MRD-HCT) - Wilmington

District of Columbia

  • Children's National Hospital (MRD-HCT) - Washington D.C.

Georgia

  • Children's Healthcare of Atlanta (MRD-HCT) - Atlanta

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2024-06-01
Est. Completion 2030-10-01
University of Rochester

636 total trials

What NCT06941389 shows while recruiting

NCT06941389 is an observational study that tracks outcomes without assigning an intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, above the 295-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (63% higher).

The record links to 1 condition, with Sickle Cell Disease (SCD) appearing as the primary indexed condition, and to 0 interventions.

NCT06941389 names 20 study sites across 10 states, led by New York, Alabama, Indiana.

Frequently Asked Questions

What is clinical trial NCT06941389 about?

NCT06941389 is a clinical study titled "Comparing the Effectiveness of Matched Related Donor Hematopoietic Stem Cell Transplantation to Disease Modifying Therapy in Pediatric Patients With Sickle Cell Disease". The WeDecide study is a large observational study comparing the long-term effects of matched related donor hematopoietic stem cell transplantation (MRD HCT) and non-transplant disease-modifying therapies (NT-DMT) for pediatric patients with sickle cell disease (SCD). The study aims to assess health-...

What is the current status of trial NCT06941389?

This trial is currently recruiting. The enrollment target is 480 participants. The study started on 2024-06-01. Estimated completion is 2030-10-01.

What conditions does trial NCT06941389 study?

This clinical trial studies the following conditions: Sickle Cell Disease (SCD).

Who is sponsoring clinical trial NCT06941389?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06941389 being conducted?

This trial has 20 study locations across Alabama, Delaware, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06941389

Source: ClinicalTrials.gov NCT06941389, the US trial registry maintained by the National Library of Medicine. NCT06941389 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.