Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607666
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-03-06
Brief Title:
Acromegaly Resistant to Conventional Dose of First Generation Somatostatin Ligands
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Acromegaly Resistant to Conventional Dose of First Generation Somatostatin Ligands
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACRO-SSA
Brief Summary:
Acromegaly is a chronic disease with a high frequency of systemic complications and reduced life span in cases of persistently active disease The remission of acromegaly through the surgical removal of the pituitary adenoma ranges from the 10 to 70 according to surgery experience tumor invasion and dimension The medical treatment can reach the control of acromegaly disease in around 35-45 of patients treated with first generation somatostatin analogues first gen-SSAs at standard dose Instead patients partially or completely resistant to treatment with first gen-SSAs may reach the control of acromegaly by treatments with high dosefrequency first gen-SSAs antagonist of GH receptor and second generation SSAs At the actual moment the scientific societies are heavily working for reaching definitive guidelines for the management of second line treatments in acromegaly patients resistant to first gen-SSAs at standard dose According to the most recent expert opinions consensus and guidelines the choice of second line treatment may be oriented by patients comorbidities and molecular characterization of the GH secreting tumors However a consensus of the clinical use of molecular biomarkers was not reached
The primary objective of this study is to define the number of patients who had reached the control of acromegaly at 6 12 and 24 months of treatment according to the following two treatment schemes Lanreotide ATG at conventional dose versus Lanreotide ATG at high dosefrequency The secondary objectives are to evaluate the role of the tumor molecular biomarkers clinical and biochemical features of acromegaly and of morphological features of GH secreting tumors in predicting the outcome of the previous detailed two treatment schemes
For reaching these aims we designed an observational retrospective mono-center study on acromegaly patients Patients will be enrolled according to strict inclusionexclusion criteria Data collection will be retrospectively conducted on molecular biomarkers eg genomic polymorphism of the gene of the GH receptor on patients blood expression of GH prolactin Ki-67 labeling index Li p53 subtype 2 and 5 of the somatostatin receptor cytokeratin pattern and number of mitosis through immunohistochemistry on paraffin-fixed samples of the patients pituitary GH secreting tumors and on clinical eg gender and age at acromegaly diagnosis and biochemical features eg random GH cycle GH and GH nadir IGF-I prolactin values at the time of acromegaly diagnosis after pituitary surgery and before starting treatment with first gen-SSAs The results of these clinical biochemical and morphological markers will be correlated to the outcome of treatment with Lanreotide ATG both at standard dose and at high dosehigh frequency
The primary objective of this study is to define the number of patients who had reached the control of acromegaly at 6 12 and 24 months of treatment according to the following two treatment schemes Lanreotide ATG at conventional dose versus Lanreotide ATG at high dosefrequency The secondary objectives are to evaluate the role of the tumor molecular biomarkers clinical and biochemical features of acromegaly and of morphological features of GH secreting tumors in predicting the outcome of the previous detailed two treatment schemes
For reaching these aims we designed an observational retrospective mono-center study on acromegaly patients Patients will be enrolled according to strict inclusionexclusion criteria Data collection will be retrospectively conducted on molecular biomarkers eg genomic polymorphism of the gene of the GH receptor on patients blood expression of GH prolactin Ki-67 labeling index Li p53 subtype 2 and 5 of the somatostatin receptor cytokeratin pattern and number of mitosis through immunohistochemistry on paraffin-fixed samples of the patients pituitary GH secreting tumors and on clinical eg gender and age at acromegaly diagnosis and biochemical features eg random GH cycle GH and GH nadir IGF-I prolactin values at the time of acromegaly diagnosis after pituitary surgery and before starting treatment with first gen-SSAs The results of these clinical biochemical and morphological markers will be correlated to the outcome of treatment with Lanreotide ATG both at standard dose and at high dosehigh frequency
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None