- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05153967
Cooperative Assessment of Late Effects for SCD Curative Therapies (COALESCE)
U01 Cooperative Assessment of Late Effects for Sickle Cell Disease Curative Therapies
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Leshana Saint Jean, PhD
- Phone Number: 6158751992
- Email: leshana.saint.jean@vumc.org
Study Contact Backup
- Name: Kristin Wuichet, PhD
- Phone Number: 6159366098
- Email: kristin.wuichet@vumc.org
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Not yet recruiting
- Children's National Medical Center
-
Contact:
- Allistair Abraham, MD
- Phone Number: 202-476-6690
- Email: AAbraham@childrensnational.org
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Not yet recruiting
- Emory University School of Medicine
-
Contact:
- Vivien Sheehan, MD, PhD
- Phone Number: 404-727-7100
- Email: vivien.sheehan@emory.edu
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Not yet recruiting
- Johns Hopkins Hospital
-
Contact:
- Richard Jones, MD
- Phone Number: 667-312-2400
- Email: rjjones@jhmi.edu
-
Bethesda, Maryland, United States, 20814
- Not yet recruiting
- National Institutes of Health Clinical Center
-
Contact:
- Courtney Fitzhugh, MD
- Phone Number: 301-402-6496
- Email: courtney.fitzhugh@nih.gov
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-9000
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Michael R. DeBaun, MD, MPH
- Phone Number: 5-3040 615-875-3040
- Email: m.debaun@vumc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Confirmed laboratory diagnosis of SCD
- Ability to give informed consent
- Ability to provide pre- and post-curative therapy data
- Treated with either one HSCT or with standard disease-modifying therapy
Exclusion Criteria
•History of non-compliance
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Pediatric Myeloablative allo-HSCT
Participants ages 4 to 17 years old with SCD who underwent or are scheduled to undergo myeloablative allo-HSCT.
|
Pediatric Standard Disease-Modifying Therapy
Participants ages 4 to 17 years old with SCD who receive standard therapy.
|
Adult Non-Myeloablative allo-HSCT
Participants ages 18 to 65 years old with SCD who underwent or are scheduled to undergo non-myeloablative allo-HSCT.
|
Adult Standard Disease-Modifying Therapy
Participants ages 18 to 65 years old with SCD who receive standard therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of longitudinal change in FEV1
Time Frame: Through study completion, an average of four years
|
Measurements of forced expiratory volume in 1 second (FEV1) based on the global lung index will be acquired from children with SCD receiving myeloablative curative therapies and adults with SCD receiving nonmyeloablative allo-HSCT, as well as from the respective control children and adult cohorts with SCD who received standard therapy.
FEV1 will be reported in liters.
(References: Eur Respir J. Volume 40 Issue 6: pages 1324-1343, 2012 June 27; Am J Hematol.
Volume 93 Issue 3: pages 408-415, 2018 March).
|
Through study completion, an average of four years
|
Percent predicted value of longitudinal change in FEV1
Time Frame: Through study completion, an average of four years
|
Percent predicted of forced expiratory volume in 1 second (FEV1) based on the global lung index will be acquired from children with SCD receiving myeloablative curative therapies and adults with SCD receiving nonmyeloablative allo-HSCT, as well as from the respective control children and adult cohorts with SCD who received standard therapy.
FEV1 will be reported in percentage.
(References: Eur Respir J. Volume 40 Issue 6: pages 1324-1343, 2012 June 27; Am J Hematol.
Volume 93 Issue 3: pages 408-415, 2018 March).
|
Through study completion, an average of four years
|
Measurement of longitudinal change in FVC
Time Frame: Through study completion, an average of four years
|
Measurements of forced volume capacity (FVC) based on the global lung index will be acquired from children with SCD receiving myeloablative curative therapies and adults with SCD receiving nonmyeloablative allo-HSCT, as well as from the respective control children and adult cohorts with SCD who received standard therapy.
FVC will be reported in liters.
(References: Eur Respir J. Volume 40 Issue 6: pages 1324-1343, 2012 June 27; Am J Hematol.
Volume 93 Issue 3: pages 408-415, 2018 March).
|
Through study completion, an average of four years
|
Percent predicted value of longitudinal change in FVC
Time Frame: Through study completion, an average of four years
|
Percent predicted of forced volume capacity (FVC) on the global lung index will be acquired from children with SCD receiving myeloablative curative therapies and adults with SCD receiving nonmyeloablative allo-HSCT, as well as from the respective control children and adult cohorts with SCD who received standard therapy.
FVC will be reported in percentage.
(References: Eur Respir J. Volume 40 Issue 6: pages 1324-1343, 2012 June 27; Am J Hematol.
Volume 93 Issue 3: pages 408-415, 2018 March).
|
Through study completion, an average of four years
|
FEV1/FVC Ratio Percentage
Time Frame: Through study completion, an average of four years
|
Percentage of FEV1/FVC ratio based on the global lung index will be acquired from children with SCD receiving myeloablative curative therapies and adults with SCD receiving nonmyeloablative allo-HSCT, as well as from the respective control children and adult cohorts with SCD who received standard therapy.
(References: Eur Respir J. Volume 40 Issue 6: pages 1324-1343, 2012 June 27; Am J Hematol.
Volume 93 Issue 3: pages 408-415, 2018 March).
FEV1/FVC will be reported in percentage.
|
Through study completion, an average of four years
|
Longitudinal change in eGFR
Time Frame: Through study completion, an average of four years
|
Estimated GFR (eGFR) as a determinant of kidney disease will be collected from children with SCD receiving myeloablative curative therapies and adults with SCD receiving nonmyeloablative allo-HSCT, as well as from the respective control children and adult cohorts with SCD who received standard therapy. The eGFR will be tested as a linear variable and using eGFR Categories according to the KDIGO 2012 Guidelines (Table 5 - Reference: Kidney Int Suppl. Volume 3 Issue 1: pages 19-62, 2013 Jan) as follows: i.G1 >/ 90 mL/min/1.73m2 ii.G2 60 - 89 mL/min/1.73m2 iii.G3a 45 - 59 mL/min/1.73m2 iv.G3b 30 - 44 mL/min/1.73m2 v.G4 15 - 20 mL/min/1.73m2 vi.G5 < 15 mL/min/1.73m2 The standard technique of measured GFR will be used and reported in mL/min/1.73m2. |
Through study completion, an average of four years
|
Longitudinal change in albuminuria levels
Time Frame: Through study completion, an average of four years
|
Data pertaining to persistent albuminuria (defined as >/ 30 mg/g creatinine on 2 evaluations) associated with a more rapid decline in eGFR on longitudinal follow-up (Reference: Blood Adv.
Volume 4 Issue 7: pages 1501-1511, 2020 Apr 14) will be tested.
Results will be reported in mg/g.
|
Through study completion, an average of four years
|
Longitudinal change in TRJV in adults with SCD treated with nonmyeloablative allo HSCT in adults
Time Frame: Through study completion, an average of four years
|
Improvement in TRJV in adults with SCD following HSCT will be acquired.
Results will be reported in m/sec.
|
Through study completion, an average of four years
|
Longitudinal change in SBP/DBP in adults with SCD treated with nonmyeloablative allo HSCT in adults
Time Frame: Through study completion, an average of four years
|
Measurements of Systolic blood pressure (SBP)/Diastolic blood pressure (DBP) in adults with SCD following HSCT will be acquired.
Results will be reported as a ratio (SBP (mmHg)/DBP (mmHg)).
|
Through study completion, an average of four years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael R DeBaun, MD, MPH, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210806
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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