Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07490392
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
40 Years
Study:
NCT07490392
Study Brief:
Protocol Section:
NCT07490392