Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455956
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Use of miRNAs in Growth Hormone Deficiency GHD
Sponsor:
University of Parma
Organization:
University of Parma
Study Overview
Official Title:
New Potential Biomarkers for Diagnosis of Growth Hormone GH Deficiency and Early Assessment of Response to GH Treatment for Appropriate Personalization of Therapy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GH-miRNA2
Brief Summary:
This study aims at improving knowledge about the diagnosis of growth hormone deficiency GHD and treatment with growth hormone GH with the goal of providing information on the presence of new biomarkers such as miRNAs for diagnostic and therapeutic purposes with the goal of establishing a personalized GH treatment scheme optimizing resources reducing costs and improving outcomes
Detailed Description:
In 200 prepubertal and pubertal subjects with the suspicion of GHD the levels of three specific circulating miRNas will be measured to establish whether they can be used for the diagnosis of GH deficiency In subjects with isolated idiopathic GHD IIGHD short statured patients born SGA Noonan and Turner syndromes and SHOX deficiency we will also assess the changes of the identified miRNAs before and after 3 months on GH therapy to verify an early growth prediction model for growth response at 12 months on treatment Finally we plan to identify any differences in these miRNAs at 3 months on treatment using daily GH versus weekly long-acting GH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None