LIFE-NETs (Life Following Excision of Neuroendocrine Tumors): a Multi-institutional Prospective Observational Cohort Study of Quality of Life After Surgery for Neuroendocrine Tumors

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Neuroendocrine tumors (NETs), often seen as chronic cancer present a survival paradox with relatively prolonged patient survival despite active disease. Treatment strategies emphasize management over cure, integrating tumor control with quality of life (QOL) considerations. Surgery is a cornerstone of NET management but demands a careful balance between its potential benefits and the morbidity risks. Current literature on post-surgical QOL is limited and non-generalizable, underscoring the need for comprehensive, multi-institutional data to inform surgical decisions. We will study QOL after surgery for NETs in a prospective multi-institutional international cohort study. Specifically, we aim to 1) describe the post-operative QOL of patients with NETs and 2) identify factors associated with QOL measures after surgery for NETs. This project will be led in partnership by the Susan Leslie Clinic for NETs at Sunnybrook Health Sciences Centre in Toronto, Canada, and the IRCCS San Raffaele ENETS Centre of Excellent in Milan, Italy, and enrol adults undergoing surgery for resection of gastro-entero-pancreatic NETs across 12 North-American and European high-volume NETs surgery centres over a 18-month period. Measures of QOL using the SF-12 Survey, the EORTC-QLQ C30 and GEPNET21 tool, and clinical symptoms assessment, will be captured prior to surgery and at 6, 12, 24, and 36 months after surgery. Mixed linear regression models with random intercepts to account for longitudinal data correlation and individual variability will be used to analyze the QOL measures over time. Patient and service users engagement (PSUE) will be integrated throughout the study continuum. This project will fill the knowledge gap in QOL after surgery for NETs, with a view to support better-informed surgical decisions and patient-centred care. The prospective, multi-institutional, and international design promises a comprehensive understanding of the impact of surgery on patient's lives, potentially shaping management pathways globally.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years old

• Diagnosis of well-differentiated grade 1 to 3 NETs via histopathology (biopsy) or imaging (measurable tumor on CT or MRI with avidity on SSTR-PET scan).

• Consents to surgery for resection of localized, loco-regional, or metastatic gastro-enteric (midgut) and pancreatic neuroendocrine tumor (GEP-NET).

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Jessica Armah, MSc
jessica.armah@sri.utoronto.ca
416-480-6100
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 246
Treatments
Resected GEP-NETs
Surgery for resection of NETs, including complete resection and cytoreduction resection, as advised by the treating physician. The extent and timing of surgery is determined by the treating physician.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov