NCT06607198: PitNET2024

Clinical-pathological Evaluation of Pit-NETs

Not yet recruiting Last updated 23 September 2024

What this trial tests

trial testing grading & staging in Pituitary in 940 participants. Not yet recruiting.

Timeline

1 October 2024

Primary endpoint
1 October 2026

1 October 2026

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	940
Start date	1 October 2024
Primary completion	1 October 2026
Estimated completion	1 October 2026
Sites	1 location across Italy

Drugs / interventions tested

• grading & staging
• PitNET morphology analysis
• Radiomics
• Molecular test: proteomics

Conditions studied

• Pituitary — all drugs for Pituitary →
• Cancer — all drugs for Cancer →
• Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, any sex, with Pituitary or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.