Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Roma La Sapienza

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Somatostatin analog; chemotherapy

    Drug

    According 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

60 Participants
are divided into 2 treatment groups
Group A: Neuroendocrine toumor group1 intervention
Group B: Control group0 interventions

Trial outcomes

Primary outcomes

1

To evaluate the modification of the angiogenetic mediator sTie2 after treatment.

Modification of sTie (soluble Tie2) after treatment

Time frame
baseline - + 1 month - +3 months

Secondary outcomes

1

To evaluate the difference in the angiogenetic mediator sTie2 between patients and controls

Comparison of basal levels of sTie between patients and controls

Time frame
baseline
2

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

Time frame
baseline
3

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

Time frame
baseline - + 1 month - +3 months
4

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)

Time frame
baseline

Other outcomes

Sponsors and contacts

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