Neuroendocrine Tumors - Patient Reported Outcomes

NCT05064150 | Active Not Recruiting

• 1 other identifier: 202104599
• Study Type: observational
• Target: 2,539
• Locations: 1 country
• Sites: 14

Brief Summary

With so many therapeutic options available (i.e.: biologic therapy, liver directed therapy, radiotherapy and chemotherapy), the purpose of this project is to partner with patients on comparative effectiveness research (CER) to achieve the goal of alleviating undue toxicity, and optimizing effectiveness and sequencing of therapy for neuroendocrine tumors (NET) patients. We will conduct a study of all newly occurring GEP-NET and lung NET cases aged 18 years and older diagnosed between 01/01/2018 through 09/30/2024 across 14 sites participating in the National Patient-Centered Clinical Research Network (PCORnet), enrolling an average of 215 patients per site over the 3 year study period (2515 patients total), allowing up to 60 months of follow-up for medical record outcomes. Participants will complete four online or paper surveys over 18 months; these surveys will focus on patient-reported outcomes, including questions on quality of life, treatment decisions, and experiences with cancer care. Survey data will be linked to participant medical record data to achieve study aims.

Conditions

Neuroendocrine Carcinoma; Gastroenteropancreatic Neuroendocrine Tumor; Lung Neuroendocrine Neoplasm; Neuroendocrine Tumors

Keywords

Patient-reported outcomes; Neuroendocrine; Quality of Life; Survival; Treatment sequencing; Symptom burden

Outcome Measures

Primary Outcomes (4)

• European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)

  Incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Responses to the QLQ-C30 will be linearly transformed to a 0-100 scale using EORTC guidelines, a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

  Change in score across baseline, 6, 12, and 18 month time points.

• European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GI.NET21)

  The QLQ-GINET21 contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) of the new module (SF21; three items) and disease-related worries (DRW; three items). Responses to the QLQ-GINET21 will be linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.

  Change in score across baseline, 6, 12, and 18 month time points.

• Sequencing of treatment regimens from electronic medical records (% of patients using modality)

  Ordering of treatment receipt i.e.: first-line, 2nd line 3rd line therapies

  Up to 5 years

• Renal function

  Creatinine clearance loss (per/Yr)

  Change in score across baseline, 6, 12, and 18 month time points.

Secondary Outcomes (10)

• Norfolk Carcinoid Symptom Score

  Change in score across baseline, 6, 12, and 18 month time points.

• Experiences with cancer care (from CANCORS)

  Change in score across baseline, 6, 12, and 18 month time points.

• Progression-free survival

  1-, 3-, and 5-year

• Overall survival

  Up to 5 years

• Adverse toxicities

  Up to 5 years

Study Arms (1)

NET patient observational cohort

Patients diagnosed with lung or gastrointestinal neuroendocrine tumors

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

Inclusion/exclusion criteria will be assessed by a combination of a computable phenotype (computer code or algorithm) that is run against participating site electronic medical record and/or tumor registry data holdings, and/or manual review of patient EMR; and patient self-report.

You may qualify if:

• (1) Adults age 18 years or older at time of NET diagnosis
• (2) Diagnosis of GEP-NET or lung NET between 1/1/2018 and 09/30/2024, as evidenced by
• (a) medical record information on diagnoses and/or medications and/or treatments and/or test results and/or clinical notes and/or procedures and/or encounters and/or tumor characteristics, and
• (b) patient self-attestation of their diagnosis.

You may not qualify if:

• Any GEP-NET/Lung NET prior to 1/1/18, as evidenced by medical record information on diagnoses and/or medications and/or treatments and/or test results and/or clinical notes and/or procedures and/or encounters and/or tumor characteristics

Sponsors & Collaborators

• Medical College of Wisconsin: collaborator
• University of Kansas Medical Center: collaborator
• University of Texas Southwestern Medical Center: collaborator
• University of Utah: collaborator
• University of Florida: collaborator
• Ohio State University: collaborator
• University of Michigan: collaborator
• University of Pittsburgh Medical Center: collaborator
• Medical University of South Carolina: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Vanderbilt University Medical Center: collaborator
• Northern California CarciNET Community: collaborator
• Neuroendocrine Cancer Awareness Network: collaborator
• Neuroendocrine Tumor Research Foundation: collaborator
• Healing NET Foundation: collaborator
• Allina Health System: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• University of Iowa: lead
• Mayo Clinic: collaborator

Study Sites (14)

University of Florida

Gainesville, Florida, 32611-5500, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center Research Institute, Inc

Kansas City, Kansas, 66103-2937, United States

Location

Regents of the University of Michigan

Ann Arbor, Michigan, 48109-1340, United States

Location

Allina Health System

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-1350, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260-3203, United States

Location

The Medical University of South Carolina

Charleston, South Carolina, 29407-4636, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9020, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Medical College of Wisconsin, Inc

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Gastro-enteropancreatic neuroendocrine tumor; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael O'Rorke, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: October 1, 2021
• Study Start: May 10, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (14)