Clinical trial · Observational
Life Following Excision of Neuroendocrine Tumors
LIFE-NETs (Life Following Excision of Neuroendocrine Tumors): a Multi-institutional Prospective Observational Cohort Study of Quality of Life After Surgery for Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine (NE) Tumors | — | UNRESOLVED | — |
| Neuroendocrine Tumor GEP Grade 1-3 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Resected GEP-NETs
- description
- 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.
Primary outcomes (1)
- measure
- Quality of life
- timeFrame
- Within 30 days before surgery (pre-operative) and at 6, 12, 24 and 36 months after surgery
- description
- Quality of life will be measured by the 12-item short-form quality of life survey (SF-12). The SF-12 is a validated tool that evaluates limitations in physical, social, and work activities due to physical or emotional problems to provide a measure of functional health and wellbeing. It evaluates 8 domains of quality of life: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. This survey has been tested both in the general population and in a variety of diseases, and is able to reflect changes in quality of life over time. Two composite scores are obtained from answers to the SF-12: the physical composite score (PCS) and the mental composite score (MCS). Average PCS and MCS for the general population are 50 points each with a standard deviation of 10 points. The SF-12 score goes from 0 to 100, with higher scores indicating better performance.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * Pre-operative diagnosis of neuroendocrine carcinoma on histopathology (biopsy) or imaging (measurable tumor on CT or MRI with avidity on FDG-PET scan and no avidity on SSTR-PET scan). * Declines surgery. * Unable to respond to study questionnaires (not proficient in local language).
References
Publications (0)
Data not yet available