Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04727723
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-06
First Post:
2020-11-20
Brief Title:
Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
Sponsor:
Advanced Accelerator Applications
Organization:
Advanced Accelerator Applications
Study Overview
Official Title:
Two Steps Italian Prospective obsErvationAL Study Assessing the Effectiveness and Outcomes Associated With LUtathera 177Lu Oxodotreotide Treatment in Adult Subjects With Unresectable or Metastatic Progressive Well Differentiated G1 and G2 Somatostatin Receptor Positive Gastroenteropancreatic-neuroendocrine Tumours GEP-NETs - REAL-LU
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REAL-LU
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-NETs who have been prescribed Lutathera in standard clinical practice
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 last enrolled patient has completed 36 months of assessments unless early termination after enrolment Data will be collected in accordance with routine clinical visits
The study duration will be 48 months in total 12 months recruitment and 36 of follow-up from the last patient in
The study duration will be 48 months in total 12 months recruitment and 36 of follow-up from the last patient in
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None