Full name of study
Safety of long-acting growth hormone in cancer survivors
Lead Applicant/Sponsor
Judith Gebauer, University Cancer Center Leipzig, Germany
Co-Applicants
Beverly Biller, Boston; Suet Ching Chen, Glasgow; Peter Clayton, Manchester; Maria Fleseriu, Portland; Andrew Hoffmann, Stanford; Gudmundur Johannson, Gothenburg; Bradley S Miller, Minneapolis; Sebastian Neggers, Rotterdam; Lars Sävendahl, Stockholm; Katharina Schilbach, Munich; Diana Vitali, Rome; Kevin Yuen, Phoenix.
GloBE-Reg Study ID: 202501_JG
Summary
Growth hormone (GH) treatment is approved for survivors of cancer who have GH deficiency. In addition to the conventional daily formulation, long-acting GH (LAGH) has also been recently approved for the treatment of GHD. This study aims to assess the safety of LAGH compared to the daily GH formulation in cancer survivors, with a specific focus on the occurrence of new cancers and relapses.
Inclusion criteria
All those who receive LAGH following the cancer diagnosis & All those who receive daily GH following the cancer diagnosis.
Data fields & Frequency of Collection
- GloBE-Reg Core Dataset
- GloBE-Reg rhGH Minimum Dataset
- In addition to the Minimum Dataset, additional cancer-related information and IGF-1 concentration and assay will need to be completed in the Diagnosis and Clinician-Reported Outcome Case Report Forms.
Frequency
Retrospective and longitudinal data are required at 12, 24, 60, and 120 months after initiation of GH treatment. 6-monthly tranches will be supplied to the investigators.
Expected outputs
Outcomes will be disseminated as a scientific report and publications.
Publication plan for authorship in outputs
The investigator will adhere to the GloBE-Reg recommendations. All current and future participating centres will be co-authors on all planned publications as long as they meet the ICMJE criteria listed. The coauthors will include those involved in study design, data provision, data extraction, data analysis and interpretation and those involved in the creation of the outputs. The support of all funders of the GloBE-Reg platform at the time the study was active will be acknowledged.
Date of Approval By GloBE-Reg Data Access Committee 17th February 2025
For further information and to participate in this study please contact info@globe-reg.net
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