About this trial
This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to first line medical therapy (study group);
Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (control group).
Disqualifiers
Severe chronic kidney disease (stage 4-5);
Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease;
Other non-neuroendocrine malignancies.
Trial population
Patients with histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic tract
Trial design
Case-control
Prospective
Treatments tested in this trial
Somatostatin analog; chemotherapy
DrugAccording to current ENETS guidelines, patients will be treated by somatostatin analogs or chemotherapy, recommended respectively as first line therapy in neuroendocrine tumours or neuroendocrine neoplasms.
Treatment groups
Trial outcomes
Primary outcomes
To evaluate the modification of the angiogenetic mediator sTie2 after treatment.
Modification of sTie (soluble Tie2) after treatment
Secondary outcomes
To evaluate the difference in the angiogenetic mediator sTie2 between patients and controls
Comparison of basal levels of sTie between patients and controls
To validate the use of circular RNAs from TEPs in NEN diagnosis
Validation of the use of circular RNAs sequencing from tumor educated platelets (TEPs) in NETs diagnosis, through the comparison between patients and controls
To evaluate the changing in circular RNAs from TEPs in NEN patients after somatostatin analogs treatment
Modification in circular RNAs sequencing from tumor educated platelets (TEPs) in patients after treatment
To compare circular and cellular angiogenesis mediators between patients and controls
Comparison of basal level of other circular and cellular angiogenesis mediators between patients and controls (Angiogenic factors: ANG1, ANG2, FGF1, FGF2, NRP1, NRP2, VEGFA, VEGFB, VEGFC, HIF1A, NOS3, PROK1, PROK2; Cytokines: CCL11, CCL2, CXCL1, CXCL10, CXCL5, CXCL6, CXCL9, IL1B, IL6, TNF; Receptors and other angiogenic factors: VEGFR1, VEGFR2, TIE2, PDGFR, TGFBR, MMP14, MMP2, MMp9, TIMP1, TIMP2, TIMP3, PROKR1, PROKR2)
Sponsors and contacts
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