RecruitingNCT04464122

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

Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study


Sponsor

University of Roma La Sapienza

Enrollment

60 participants

Start Date

Sep 14, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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).

Exclusion Criteria3

  • Severe chronic kidney disease (stage 4-5);
  • Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease;
  • Other non-neuroendocrine malignancies.

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Interventions

DRUGSomatostatin analog; chemotherapy

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.


Locations(1)

Andrea M Isidori

Rome, Italy, Italy

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