Actively Recruiting

Age: 18Years +
All Genders
ID06981455

Life Following Excision of Neuroendocrine Tumors: An International Multi-institutional Observational Study of Quality of Life After Surgery

Led by Sunnybrook Health Sciences Centre · Updated on 2025-05-20

246

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Neuroendocrine tumors (NETs) are a type of cancer known for their slow progression, often described as a "chronic cancer" due to patients living with active disease for many years. This research evaluates quality of life (QOL) after surgery for NETs, aiming to better understand patients' experiences and factors that influence their well-being after surgical treatment. The study is a prospective, international, multi-institutional observational cohort conducted by centers in North America and Europe, focusing on adults undergoing surgery for gastro-entero-pancreatic NETs. The study follows patients who have surgery to remove NETs, including complete tumor removal or cytoreduction, as decided by their doctors. Researchers will collect information before surgery and at 6, 12, 24, and 36 months afterward, using validated QOL surveys and symptom assessments. The study includes an 18-month recruitment period and a 36-month follow-up for each patient. Patient engagement is integrated throughout to ensure the study addresses meaningful outcomes. Participants will complete quality of life questionnaires and clinical symptom assessments at several time points before and after surgery. The research team will analyze changes over time and explore how age, sex, tumor location, tumor grade, and type of surgery relate to QOL outcomes. Safety and patient experience data will be monitored, with interim analysis planned one year after recruitment ends and final analysis after 36 months. This study aims to provide comprehensive, reliable information to guide surgical decisions and improve patient-centered care globally.

CONDITIONS

Brief Title

Life Following Excision of Neuroendocrine Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years old
  • Diagnosis of well-differentiated grade 1 to 3 neuroendocrine tumors confirmed by biopsy or imaging
  • Planned surgery for removal of localized, regional, or metastatic gastro-enteric or pancreatic neuroendocrine tumors
  • Ability to consent to surgery and participate in study assessments
Not Eligible

You will not qualify if you...

  • Diagnosis of neuroendocrine carcinoma based on biopsy or imaging
  • Declines to undergo surgery
  • Unable to complete study questionnaires due to language barriers

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Varies depending on surgery and recovery

Participants undergo surgery for removal of neuroendocrine tumors with care immediately after surgery.

1 surgery visit and immediate post-operative care

Post-operative Follow-up

Duration - 36 months

Participants complete quality of life assessments before surgery and at 6, 12, 24, and 36 months after surgery to monitor recovery and well-being.

5 visits (1 pre-operative and 4 post-operative visits)

Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

J

Jessica Armah, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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