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Comprehensive efficacy and safety assessment of growth hormone replacement therapy in children with sellar tumors: a prospective observational study.

Comprehensive efficacy and safety assessment of growth hormone replacement therapy in children with sellar tumors: a prospective observational study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100746
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-04-26
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth hormone deficiency, GHD

Interventions

Observation group:None
Group treated with rhGH:None

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Clinically diagnosed as intracranial tumor; 2.Tumor resection and/or chemoradiotherapy was performed; 3.Patients with postoperative GHD should receive growth hormone supplementation based on clinical and laboratory results(Consensus recommends:Children with clinical growth retardation, sellar lesions, and >= 1 other pituitary hormone deficiency can be diagnosed as GHD based on the fact that IGF-1 is lower than the normal range corresponding to the same gender, without GH provocation test. When the level of IGF-1 is within the normal range, GH stimulation test should be performed to recognize GHD); 4.If there are multiple hormone deficiencies, corticosteroid and thyroid hormone deficiencies should be corrected in turn before growth hormone replacement therapy. 5.No previous use of growth hormone;

Exclusion criteria

Exclusion criteria: 1.Epiphyseal closure; 2.Patients with underlying tumor recurrence showing any signs of progression; 3.Previous use of height-improving drugs (including growth hormone, IGF-1 supplements, and growth hormone receptor agonists); 4.Allergic to growth hormone; 5.Any other condition that the investigator considers inappropriate for inclusion in the study;

Design outcomes

Primary

MeasureTime frame
Annual growth rate(HV);

Secondary

MeasureTime frame
Ratio of the subjects' HV faster than 6cm/year, ?Ht-SDS, ?IGF-1 SDS;Comprehensive outcome : score of life quality;Safty: AE and SAE;

Countries

China

Contacts

Public ContactXie Rongrong

Children's Hospital of Soochow University

xierong_wx@163.com+86 512 80698212

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026