MedTrace Logo

Asymptomatic Small Pancreatic Endocrine Neoplasms.

NCT03084770 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-01-18

No results posted yet for this study

Summary

The aim of the study is to evaluate the most appropriate management of sporadic asymptomatic non-functioning pancreatic neuroendocrine neoplasms (NF-PNEN) ≤ 2 cm. P NF-PNEN management will be decided at the hospital and all therapeutics decision will be decided/coordinated by the treating physician.

Patients will be either submitted to surgical resection or to active surveillance.

Conditions

  • Non Functioning Pancreatic Endocrine Tumor

Interventions

DIAGNOSTIC_TEST

Radiological imaging studies

Patients will be submitted to radiological imaging studies (CT scan and/or MRI and/ or 68Gallium PET/CT and/or Octreoscan and/or EUS+FNAand/or Octreoscan and/or EUS+FNA) at diagnosis, and then every 6 months for the first two years and yearly thereafter for five years in the absence of significant changes on imaging or symptoms appearance. Every 12 months (or 6 months for patients with Ki67\> 2%) a high quality imaging (CT scan or MRI) is required.

OTHER

Quality of Life Assessment

quality of life and the perceived burden of surveillance or follow-up after surgery for participants, will be investigated by administrating HADS questionnaire and EORTC QLQ-C30 (version 3) and EORTC QLQ-GI.NET21 Module.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Massimo Falconi, Professor · IRCCS San Raffaele

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084770 on ClinicalTrials.gov