Stem Cell Transplant ComplicationsNCT03482154
Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
An observational study of Stem Cell Transplant Complications and Hyperglycemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Stem Cell Transplant Complications, Hyperglycemia, Hypoglycemia
- What is being tested?
- Hematopoietic Stem Cell Transplant
- Type of treatment
- Surgery or procedure
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2016to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients who received hematopoietic stem cell transplants with the Bone Marrow Transplant Program at Children's Hospital Colorado from January 1, 2007 to July 31, 2016.
Who may be able to join
- Age 0 to 30 years old at time of transplant
- Bone Marrow Transplant (BMT) recipient at Children's Hospital Colorado (CHCO) between 1/1/2007 and 7/31/2016
Who cannot join
- Preexisting diabetes mellitus or known hyperglycemia
- Inadequate blood glucose data for analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.
Read the detailed description
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.
- Being tested
- Hematopoietic Stem Cell Transplant
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic Stem Cell TransplantProcedure or surgery
Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.
| Study group | Role | What they receive |
|---|---|---|
| With Malglycemia | Not described Receives: Procedure: Hematopoietic Stem Cell Transplant | |
| Without Malglycemia | Not described Receives: Procedure: Hematopoietic Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients
hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)
Measured: Transplant Day -14 to +100
Number of patients with versus without malglycemia who experience infection
It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence
Measured: Transplant Day 0 to +100
Secondary outcomes (3)
Determine whether specific exposures are associated with increased occurrence of malglycemia
The occurrence of the outcome, malglycemia, with be assessed for differences in incidence that may occur as a result of age, medication exposures (use of glucocorticoids, asparaginase, total parenteral nutrition (TPN), or calcineurin inhibitors), underlying diagnosis, and transplant type
Measured: Transplant Day -14 to +100
Survival rate of patients with versus without malglycemia
It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant mortality. This outcome will be assessed for differences in incidence based on malglycemia occurrence
Measured: Transplant Day 0 through date of relapse or death
Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia
It is hypothesized that patients who experience malglycemia will have an increased rate of GVHD. This outcome will be assessed for differences in incidence based on malglycemia occurrence
Measured: Transplant Day 0 through date of relapse or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start6 Sep 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenna Sopfe, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482154
- Sponsor's protocol ID
- 16-1496.cc
- Status last verified
- Sep 2019
- First submitted
- 15 Mar 2018
- Last updated
- 30 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho S, Vigers T, Pyle L, Franklin A, Sopfe J, Jeney F, Forlenza G. Composite Metric of Glycemic Control Q-Score Is Elevated in Pediatric and Adolescent/Young Adult Hematopoietic Stem Cell Transplant Recipients. Diabetes Technol Ther. 2023 Feb;25(2):116-121. doi: 10.1089/dia.2022.0246. Epub 2022 Dec 29.
PubMed 36511871Sopfe J, Pyle L, Keating AK, Campbell K, Liu AK, Wadwa RP, Verneris MR, Giller RH, Forlenza GP. Malglycemia is associated with poor outcomes in pediatric and adolescent hematopoietic stem cell transplant patients. Blood Adv. 2019 Feb 12;3(3):350-359. doi: 10.1182/bloodadvances.2018021014.
PubMed 30718242
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
- ClinicalTrials.gov ID
- NCT03482154
- Acronym / sponsor ID
- 16-1496.cc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.
Detailed description
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Malglycemia | – | Procedure: Hematopoietic Stem Cell Transplant |
| Without Malglycemia | – | Procedure: Hematopoietic Stem Cell Transplant |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients who received hematopoietic stem cell transplants with the Bone Marrow Transplant Program at Children's Hospital Colorado from January 1, 2007 to July 31, 2016.
Key inclusion criteria (2 listed)
- Age 0 to 30 years old at time of transplant
- Bone Marrow Transplant (BMT) recipient at Children's Hospital Colorado (CHCO) between 1/1/2007 and 7/31/2016
Key exclusion criteria (2 listed)
- Preexisting diabetes mellitus or known hyperglycemia
- Inadequate blood glucose data for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematopoietic Stem Cell TransplantAllogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses. | Procedure or surgery | With Malglycemia, Without Malglycemia |
Primary outcome
Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients
Time frame: Transplant Day -14 to +100
hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)
Number of patients with versus without malglycemia who experience infection
Time frame: Transplant Day 0 to +100
It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence
3 secondary outcomes
Determine whether specific exposures are associated with increased occurrence of malglycemia
Time frame: Transplant Day -14 to +100
Survival rate of patients with versus without malglycemia
Time frame: Transplant Day 0 through date of relapse or death
Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia
Time frame: Transplant Day 0 through date of relapse or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 36511871Cho S, Vigers T, Pyle L, Franklin A, Sopfe J, Jeney F, Forlenza G. Composite Metric of Glycemic Control Q-Score Is Elevated in Pediatric and Adolescent/Young Adult Hematopoietic Stem Cell Transplant Recipients. Diabetes Technol Ther. 2023 Feb;25(2):116-121. doi: 10.1089/dia.2022.0246. Epub 2022 Dec 29.
- Derived from this study: PubMed 30718242Sopfe J, Pyle L, Keating AK, Campbell K, Liu AK, Wadwa RP, Verneris MR, Giller RH, Forlenza GP. Malglycemia is associated with poor outcomes in pediatric and adolescent hematopoietic stem cell transplant patients. Blood Adv. 2019 Feb 12;3(3):350-359. doi: 10.1182/bloodadvances.2018021014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenna Sopfe, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant Complications and Hyperglycemia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients (time frame: Transplant Day -14 to +100). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482154, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.