NCT07490392

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
111mo left

Started Jan 2027

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2036

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2036

Last Updated

March 24, 2026

Status Verified

December 1, 2025

Enrollment Period

9.1 years

First QC Date

March 11, 2026

Last Update Submit

March 18, 2026

Conditions

PediatricsHematopoietic Stem Cells Transplantation

Outcome Measures

Primary Outcomes (3)

  • 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)

    Through study completion, an average of 10.5 years

  • 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)

    Through study completion, an average of 10.5 years

  • 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)

    Through study completion, an average of 10.5 years

Secondary Outcomes (1)

  • To describe the impact of chemotherapy on growth outcomes in pediatric oncology patients who underwent or did not undergo prepubertal HSCT.

    Through study completion, an average of 10.5 years

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Central Study Contacts

Federico Baronio

CONTACT

00390512144816federico.baronio@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 24, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

February 13, 2036

Study Completion (Estimated)

February 13, 2036

Last Updated

March 24, 2026

Record last verified: 2025-12

Locations

IT(1)