Growth and Endocrinological Outcomes in Patients Who Underwent or Did Not Undergo Haematopoietic Stem Cell Transplantation in Prepubertal Age

Starting soon

Conditions studied: Hematopoietic Stem Cells Transplantation, Pediatrics

In brief

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.

Key facts

Study ID

NCT07490392

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

300

Starts

2027-01-01

Expected to finish

2036-02-13

Last updated by the study team

2026-03-24

Who can join

Age: 5 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy

Full record on ClinicalTrials.gov

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