Hematopoietic Stem Cells TransplantationNCT07490392
Growth and Endocrinological Outcomes in Patients Who Underwent or Did Not Undergo Haematopoietic Stem Cell Transplantation in Prepubertal Age
An observational study of Hematopoietic Stem Cells Transplantation and Pediatrics, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This observational study evaluates growth and endocrine outcomes in pediatric oncology patients who underwent prepubertal HSCT compared to those who did not. The study focuses on final height, pubertal growth spurt, and sex hormone production, with data collected retrospectively and prospectively through standard… Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Hematopoietic Stem Cells Transplantation, Pediatrics
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2027to 13 Feb 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric oncology patients who, in the prepubertal period, either underwent or did not undergo HSCT between January 2005 and December 2020, with subsequent endocrinological follow-up to assess growth progression conducted until the end of pubertal development at the Endocrine-Metabolic Diseases Program, UOC Pediatrics, IRCCS AOUBo.
Who may be able to join
- Prepubertal HSCT Group - Pediatric Oncology Patients
- HSCT performed for pediatric oncology between January 2005 and December 2020;
- Pubertal development not yet initiated at the time of HSCT (testicular volume < 4 ml bilaterally, uterine volume < 2.5 ml).
- Non-HSCT Group - Pediatric Oncology Patients
- Diagnosis of pediatric oncology between January 2005 and December 2020;
- No HSCT performed before the onset of pubertal development (testicular volume < 4 ml bilaterally, uterine volume < 2.5 ml) during the same period.
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- For Both Groups
- Received prepubertal chemotherapy including at least one of the following agents: cyclophosphamide, ifosfamide, procarbazine, cisplatin, carboplatin, melphalan, thiotepa, busulfan, treosulfan;
- Spontaneous pubertal development with autonomous progression, without the need for exogenous hormone therapy (testosterone or estradiol);
- Endocrinological follow-up to assess growth progression conducted until the end of pubertal development at the Endocrine-Metabolic Diseases Program, UOC Pediatrics, IRCCS AOUBo;
- Obtain Informed consent.
Who cannot join
- Delayed puberty (testicular volume < 4 ml at age > 14 years or Tanner stage 2 breast development at age > 13 years) requiring exogenous hormone therapy with testosterone or estradiol;
- For pediatric oncology patients not undergoing prepubertal HSCT, having received HSCT during pubertal development.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Federico Baronio, MD, 00390512144816, federico.baronio@aosp.bo.it
About this study
This observational study evaluates growth and endocrine outcomes in pediatric oncology patients who underwent prepubertal HSCT compared to those who did not. The study focuses on final height, pubertal growth spurt, and sex hormone production, with data collected retrospectively and prospectively through standard clinical follow-up.
Read the detailed description
Hematopoietic stem cell transplantation (HSCT) is a key treatment for pediatric oncology patients but may lead to long-term endocrine and growth complications, including thyroid dysfunction, adrenal insufficiency, impaired bone mineral density, growth deficits, and gonadal dysfunction. This observational cohort study aims to describe growth and endocrine outcomes at specific pubertal stages in pediatric oncology patients who underwent prepubertal HSCT, compared to those who did not receive HSCT in the same age period. Primary objectives include assessing attainment of final height relative to target height, evaluating pubertal growth spurt contribution, and quantifying pubertal sex hormone production (testosterone in males, estradiol in females). Secondary objectives include comparing auxological and endocrine parameters between subgroups that did or did not reach target height, and evaluating the impact of prepubertal exposure to gonadotoxic chemotherapy on growth outcomes. Data will be collected retrospectively and prospectively at key developmental time points according to standard clinical follow-up, without study-specific interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether pediatric oncology patients, who underwent or did not undergo prepubertal HSCT, achieve a final height (FH) within their target height (TH) range.
Height (cm, SDS)
Measured: Through study completion, an average of 10.5 years
To assess whether the pubertal growth spurt, defined as the phase of maximum growth velocity, provides a sufficient contribution for pediatric oncology patients, who underwent or did not undergo prepubertal HSCT, to achieve their target height (TH).
Height (cm, SDS)
Measured: Through study completion, an average of 10.5 years
To quantify pubertal testosterone or estradiol production in pediatric oncology patients, who underwent or did not undergo prepubertal HSCT, in order to assess its adequacy in supporting linear growth.
Height (cm, SDS)
Measured: Through study completion, an average of 10.5 years
Secondary outcomes (1)
To describe the impact of chemotherapy on growth outcomes in pediatric oncology patients who underwent or did not undergo prepubertal HSCT.
Height (cm, SDS)
Measured: Through study completion, an average of 10.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion13 Feb 2036 (estimated)
- Study completion13 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cells TransplantationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Baronio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490392
- Sponsor's protocol ID
- GRACE
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Endocrinological Outcomes in Patients Who Underwent or Did Not Undergo Haematopoietic Stem Cell Transplantation in Prepubertal Age
- ClinicalTrials.gov ID
- NCT07490392
- Acronym / sponsor ID
- GRACE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 13 Feb 2036 (estimated)
- Study completion
- 13 Feb 2036 (estimated)
- First posted
- 24 Mar 2026 (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 observational study evaluates growth and endocrine outcomes in pediatric oncology patients who underwent prepubertal HSCT compared to those who did not. The study focuses on final height, pubertal growth spurt, and sex hormone production, with data collected retrospectively and prospectively through standard clinical follow-up.
Detailed description
Hematopoietic stem cell transplantation (HSCT) is a key treatment for pediatric oncology patients but may lead to long-term endocrine and growth complications, including thyroid dysfunction, adrenal insufficiency, impaired bone mineral density, growth deficits, and gonadal dysfunction. This observational cohort study aims to describe growth and endocrine outcomes at specific pubertal stages in pediatric oncology patients who underwent prepubertal HSCT, compared to those who did not receive HSCT in the same age period. Primary objectives include assessing attainment of final height relative to target height, evaluating pubertal growth spurt contribution, and quantifying pubertal sex hormone production (testosterone in males, estradiol in females). Secondary objectives include comparing auxological and endocrine parameters between subgroups that did or did not reach target height, and evaluating the impact of prepubertal exposure to gonadotoxic chemotherapy on growth outcomes. Data will be collected retrospectively and prospectively at key developmental time points according to standard clinical follow-up, without study-specific interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric oncology patients who, in the prepubertal period, either underwent or did not undergo HSCT between January 2005 and December 2020, with subsequent endocrinological follow-up to assess growth progression conducted until the end of pubertal development at the Endocrine-Metabolic Diseases Program, UOC Pediatrics, IRCCS AOUBo.
Key inclusion criteria (11 listed)
- Prepubertal HSCT Group - Pediatric Oncology Patients
- HSCT performed for pediatric oncology between January 2005 and December 2020;
- Pubertal development not yet initiated at the time of HSCT (testicular volume < 4 ml bilaterally, uterine volume < 2.5 ml).
- Non-HSCT Group - Pediatric Oncology Patients
- Diagnosis of pediatric oncology between January 2005 and December 2020;
Key exclusion criteria (2 listed)
- Delayed puberty (testicular volume < 4 ml at age > 14 years or Tanner stage 2 breast development at age > 13 years) requiring exogenous hormone therapy with testosterone or estradiol;
- For pediatric oncology patients not undergoing prepubertal HSCT, having received HSCT during pubertal development.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess whether pediatric oncology patients, who underwent or did not undergo prepubertal HSCT, achieve a final height (FH) within their target height (TH) range.
Time frame: Through study completion, an average of 10.5 years
Height (cm, SDS)
To assess whether the pubertal growth spurt, defined as the phase of maximum growth velocity, provides a sufficient contribution for pediatric oncology patients, who underwent or did not undergo prepubertal HSCT, to achieve their target height (TH).
Time frame: Through study completion, an average of 10.5 years
Height (cm, SDS)
To quantify pubertal testosterone or estradiol production in pediatric oncology patients, who underwent or did not undergo prepubertal HSCT, in order to assess its adequacy in supporting linear growth.
Time frame: Through study completion, an average of 10.5 years
Height (cm, SDS)
1 secondary outcome
To describe the impact of chemotherapy on growth outcomes in pediatric oncology patients who underwent or did not undergo prepubertal HSCT.
Time frame: Through study completion, an average of 10.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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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.
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 Hematopoietic Stem Cells Transplantation and Pediatrics, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 11 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: opening soon, as of the sponsor's last update on 24 Mar 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Baronio (00390512144816, federico.baronio@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether pediatric oncology patients, who underwent or did not undergo prepubertal HSCT, achieve a final height (FH) within their target height (TH) range. (time frame: Through study completion, an average of 10.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.