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.
Eligibility
Sex
ALL
Min age
5 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria:
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.
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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
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. — 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). — 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. — Through study completion, an average of 10.5 years Height (cm, SDS)
Trial sites (1)
Facility
City
Region
Status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna
Bologna
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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