Clinical-pathological Evaluation of Pit-NETs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: grading & staging, PitNET morphology analysis, Radiomics, Molecular test: proteomics.
- Who it may be relevant to
- Registry conditions: Pituitary, Cancer, Neuroendocrine Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical-pathological Assessment of Pit-NETs: Data From a Large Multicenter Patients Cohort
Overview
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 and/or 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.
Interventions
- Diagnostic test grading & staging
To investigate the following pathological features of PitNET cell lineage-specific transcription factors, cell type specification by hormone production, proliferative index, p53, mitotic count, expression of somatostatin receptors - Diagnostic test PitNET morphology analysis
Revision of the pre-surgical magnetic resonance images (MRIs): tumor maximum diameter, volume, sites of tumor extensions and invasion, and grading of cavernous sinus invasion - Diagnostic test Radiomics
To investigate radiomics features of PitNETs - Diagnostic test Molecular test: proteomics
To investigate on PitNets 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)\]
Primary outcome measures
- Grating and staging [Time frame: 2 years]
Secondary outcome measures (3)
- PitNET morphology analysis [Time frame: 2 years]
- Radiomics [Time frame: 2 years]
- Molecular test: proteomics [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Consecutive patients older than 18 years;
- availability of tumor samples for the required pathology analyses;
- clinico-radiological follow-up of at least 5-10 years
Exclusion criteria
\- Not applicable for this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ANATOMIA PATOLOGICA — Rome
Identifiers
NCT: NCT06607198 · 6859