Life Following Excision of Neuroendocrine Tumors

NCT06981455 | Recruiting

• 1 other identifier: SHSC-REB-6147
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine (NE) Tumors; Neuroendocrine Tumor GEP Grade 1-3

Keywords

surgery; quality of life; carcinoid; neuroendocrine

Outcome Measures

Primary Outcomes (1)

• Quality of life

  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.

  Within 30 days before surgery (pre-operative) and at 6, 12, 24 and 36 months after surgery

Other Outcomes (2)

• Self-reported patient symptoms

  6, 12, 24 and 36 months after surgery

• QoL questionnaire EORTC-QLQ C30

  within 30 days of surgery and at 6, 12, 24 and 36 months after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery for resection of gastro-entero-pancreatic neuroendocrine tumors.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms; Carcinoid Tumor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Jessica Armah, MSc

CONTACT

416-480-6100; jessica.armah@sri.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 20, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)