Using microRNAs to improve growth response after growth hormone treatment
The Use of miRNA Panel as a Growth Plate Marker of Short-term Response to GH
This study is trying to see if certain tiny molecules in the body can help doctors predict how well kids with growth hormone deficiencies will respond to growth hormone treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Faculdade de Ciências Médicas da Santa Casa de São Paulo Academic / other |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT05946915 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of microRNAs as potential biomarkers for predicting growth response in patients receiving recombinant human growth hormone (GH) therapy. It recognizes the variability in individual responses to GH treatment and seeks to identify genetic markers that may correlate better with clinical outcomes than traditional biomarkers. By analyzing the expression of specific microRNAs, the study hopes to enhance the understanding of growth plate dynamics and improve treatment personalization for patients with growth hormone deficiencies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a GH stimulation test showing a peak concentration of less than 5 ng/ml and evidence of ectopic posterior pituitary gland.
Not a fit: Patients with chronic diseases, those requiring prolonged high doses of glucocorticoids, or those with advanced bone age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of growth response, allowing for tailored GH therapy and improved outcomes for patients.
How similar studies have performed: While there have been studies exploring genetic markers in GH treatment, the specific focus on microRNAs as growth plate markers is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * GH stimulation test showing GH-peak concentration \<5ng/ml, combined to magnetic resonance imaging showing Posterior Pituitary Ectopic gland (EPP). Patients with combined hormone deficiencies must be compensated during the study period. Exclusion Criteria: * chronic diseases, need of prolonged supraphysiologic doses of glucocorticoids, bone age \>14 years or \>16 years (girls and boys, respectively), patients missing adequate follow-up
Where this trial is running
São Paulo, SP
- Santa Casa SP School of Medical Sciences — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Study coordinator: Carlos A Longui, MD
- Email: carloslongui@msn.com
- Phone: 55-11-983266815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.