Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:53 PM
Study NCT ID:
NCT07490392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth and Endocrinological Outcomes in Patients Who Underwent or Did Not Undergo Haematopoietic Stem Cell Transplantation in Prepubertal Age
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
Official Title:
Growth and Endocrinological Outcomes in Patients Who Underwent or Did Not Undergo Haematopoietic Stem Cell Transplantation in Prepubertal Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: