Status:
ACTIVE_NOT_RECRUITING
Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
Lead Sponsor:
Advanced Accelerator Applications
Conditions:
Gastroenteropancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18-100 years
Brief Summary
This is a multicentre long-term non-interventional study of adult subjects diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-N...
Detailed Description
Data on patients will be collected from the date when patient consent was obtained, during treatment with Lutathera® and for a follow-up period until end of study (EOS), defined as the time when the l...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained prior to any data collection.
- Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET).
- Aged ≥18 years.
- Patients must be naïve to treatment with Lutathera® at enrolment.
Exclusion
- Participation in a current or prior investigational study within 30 days preceding enrolment or within 5 half-lives of the investigational product, whichever is longer.
Key Trial Info
Start Date :
March 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04727723
Start Date
March 9 2021
End Date
March 31 2026
Last Update
October 3 2025
Active Locations (18)
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1
Novartis Investigative Site
Alessandria, Italy
2
Novartis Investigative Site
Bologna, Italy
3
Novartis Investigative Site
Brescia, Italy
4
Novartis Investigative Site
Cona, Italy