Exploring miRNAs for diagnosing growth hormone deficiency
New Potential Biomarkers for Diagnosis of Growth Hormone (GH) Deficiency and Early Assessment of Response to GH Treatment for Appropriate Personalization of Therapy
University of Parma · NCT06455956
This study is testing whether certain microRNAs in the blood can help diagnose growth hormone deficiency in children and see how they change with different growth hormone treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 2 Years to 15 Years |
| Sex | All |
| Sponsor | University of Parma (other) |
| Locations | 1 site (Parma, Emilia-Romagna) |
| Trial ID | NCT06455956 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the potential of specific circulating microRNAs (miRNAs) as biomarkers for diagnosing growth hormone deficiency (GHD) in children. It involves measuring miRNA levels in 200 prepubertal and pubertal subjects suspected of having GHD, including those with isolated idiopathic GHD and other related conditions. The study aims to assess changes in miRNA levels before and after three months of growth hormone therapy to develop a predictive model for growth response. Additionally, it will compare the effects of daily versus long-acting growth hormone treatments on these biomarkers.
Who should consider this trial
Good fit: Ideal candidates include children with short stature and suspected or confirmed growth hormone deficiency.
Not a fit: Patients with underlying genetic conditions or chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and personalized treatment plans for children with growth hormone deficiency.
How similar studies have performed: While the use of miRNAs as biomarkers is a novel approach, similar studies have shown promise in other conditions, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for aim 1: * Children with short stature and suspicion of GHD * Subjects with organic GH deficiency Exclusion criteria for aim 1: -Subjects with underlying genetic conditions and chronic diseases Inclusion Criteria for aim 2-3-5: * patients having confirmed GHD enrolled for aim 1 * patients with growth failure and born SGA (\>4 yr of age) * patients with Noonan and Turner syndrome and growth failure * patients with short stature homeobox-containing gene deficiency (SHOXD) and growth failure Inclusion Criteria for aim 4: \- Isolated idiopathic prepubertal naive GHD subjects on long-acting versus daily GH therapy
Where this trial is running
Parma, Emilia-Romagna
- University of Parma — Parma, Emilia-Romagna, Italy (RECRUITING)
Study contacts
- Principal investigator: Maria E Street, MD, PhD — University of Parma
- Study coordinator: Maria E Street, MD, PhD
- Email: mariaelisabeth.street@unipr.it
- Phone: +39 0521 033557
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.
Conditions: Growth Hormone Deficiency, growth hormone, miRNA, growth hormone deficiency, growth hormone treatment, small for gestational age, Turner syndrome, Noonan syndrome