About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
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.
Disqualifiers
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 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.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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)
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)
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)
Secondary outcomes
To describe the impact of chemotherapy on growth outcomes in pediatric oncology patients who underwent or did not undergo prepubertal HSCT.
Height (cm, SDS)
Sponsors and contacts
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