Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607198
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Clinical-pathological Evaluation of Pit-NETs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical-pathological Assessment of Pit-NETs Data From a Large Multicenter Patients Cohort
Status:
NOT_YET_RECRUITING
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:
PitNET2024
Brief Summary:
Pituitary adenomas namely pituitary neuroendocrine tumors PitNETs are recognized as rare neoplasia by national and international institutions
Albeit most PitNETs are slow-growing with an indolent behavior about one-third do not achieve biochemical control recur re-grow and resist conventional treatments
The predictors of aggressive behavior have not been identified for PitNETs In 2013 Trouillas and coworkers developed a five tiered clinicopathological score by mixing histopathological data and clinico-radiological evidence of invasion This system proved of prognostic value Nonetheless unlike for NET of gut and lung no formal grading andor staging tools were developed In addition PitNETs have not been thoroughly investigated by radiomics to predict clinical behavior nor have druggable pathways been elucidated in PitNET cells to unveil new potential therapeutic approaches
The first aim of this project is to define grading and staging tools for PitNETs based on i lineage-specific transcription factors ii cell type specification by hormone production prolactin TSH LH FSH ACTH GH or none iii integration of standard radiological measures with recognized tools for clinical and pathological staging
The second aim of this project is to investigate radiomics features as predictors of PitNETs behavior prognosis and treatment outcome
The third aim of this project is to investigate whether the expression of molecular biomarkers Vascular Endothelial Growth Factor VEGF Epithelial Growth Factor Receptor EGFR somatostatin receptors 1-5 SSTRs Fibroblast Growth Factor FGF mTOR mammalian target of rapamycin Programmed cells Death 1 PD1 and its ligands PD-L1 and Cytotoxic T Lymphocyte Associated protein 4 CTLA4 may impact on patients prognosis Identifying new molecular pathways may help fine-tune and schedule the emerging targeted therapies for aggressive PitNETs including mTOR inhibitors VEGF EGFR and immune check-point inhibitors
This study will investigate a large multicenter retrospective series of 740 PitNET patients and a prospective cohort of 200 patients to reach these objectives
Albeit most PitNETs are slow-growing with an indolent behavior about one-third do not achieve biochemical control recur re-grow and resist conventional treatments
The predictors of aggressive behavior have not been identified for PitNETs In 2013 Trouillas and coworkers developed a five tiered clinicopathological score by mixing histopathological data and clinico-radiological evidence of invasion This system proved of prognostic value Nonetheless unlike for NET of gut and lung no formal grading andor staging tools were developed In addition PitNETs have not been thoroughly investigated by radiomics to predict clinical behavior nor have druggable pathways been elucidated in PitNET cells to unveil new potential therapeutic approaches
The first aim of this project is to define grading and staging tools for PitNETs based on i lineage-specific transcription factors ii cell type specification by hormone production prolactin TSH LH FSH ACTH GH or none iii integration of standard radiological measures with recognized tools for clinical and pathological staging
The second aim of this project is to investigate radiomics features as predictors of PitNETs behavior prognosis and treatment outcome
The third aim of this project is to investigate whether the expression of molecular biomarkers Vascular Endothelial Growth Factor VEGF Epithelial Growth Factor Receptor EGFR somatostatin receptors 1-5 SSTRs Fibroblast Growth Factor FGF mTOR mammalian target of rapamycin Programmed cells Death 1 PD1 and its ligands PD-L1 and Cytotoxic T Lymphocyte Associated protein 4 CTLA4 may impact on patients prognosis Identifying new molecular pathways may help fine-tune and schedule the emerging targeted therapies for aggressive PitNETs including mTOR inhibitors VEGF EGFR and immune check-point inhibitors
This study will investigate a large multicenter retrospective series of 740 PitNET patients and a prospective cohort of 200 patients to reach these objectives
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