Neuroendocrine Tumors - Patient Reported Outcomes

Study Purpose

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 01/01/2019 through 12/31/2023 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 (~3,000 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - (1) Adults age 18 years or older at time of NET diagnosis.
  • - (2) Diagnosis of GEP-NET or lung NET between 1/1/2019 and 12/31/2023, 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.

Exclusion Criteria:

Any GEP-NET/Lung NET prior to 1/1/19, 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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Iowa
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael O'Rorke, PhD
Principal Investigator Affiliation University of Iowa
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor, Lung Neuroendocrine Neoplasm, Neuroendocrine Carcinoma
Additional Details

NETs are a group of neoplasms that occur most frequently in the gastrointestinal tract, pancreas and the lungs, collectively referred to as gastroenteropancreatic (GEP-NETs) and lung-NETs. There are currently fewer than 180,000 patients living with this condition in the United States, meeting the criteria for rare disease status. NETs are typically slow growing, with vague signs and a myriad of symptoms (carcinoid syndrome) leading to diagnostic delays. Thus, NET patients typically experience a prolonged clinical course with active disease, and many have significant symptom burdens. However, assessment of quality of life outside of therapy trials remains scarce and of poor quality. What's more, over half of GEP-NETs are diagnosed with spread of their disease at diagnosis and are not candidates for curative surgery. Fortunately, many of these tumors are amenable to long-term medical treatment with somatostatin analogues (SSAs)- which slow down the production of hormones, especially serotonin, which helps to control the symptoms of carcinoid syndrome. However, living with distant spread of the disease increases the probability for the disease to progress. Following failure of first-line SSA therapy there are no clear consensus guidelines as to the optimum sequencing of other therapeutic options. NET patients are left wondering not only 'what therapy would be best to try next?', but 'if I were to take this option now, what treatment options will be closed off to me in the future?' and clinicians are unsure as to how best to tailor treatment selection on the characteristics of the patient and their tumor. There is currently no large nationally recruiting prospective (forward in time) observational study of NET patients. Our large study will robustly generate real-world evidence on the frequency and sequence of commonly used treatments for GEP and lung NET patients in relation to Patient Reported Outcomes (PROs) and survival/progression, endpoints that matter most to NET patients, their caregivers, and clinicians involved in their care. Given the lack of consensus guidelines as to the optimum sequencing of treatments, evidence generated in this study will aid patient (and clinician) navigation and selection of the next most appropriate therapy, accounting for the preferences and needs of the individual patient, whilst respecting the underlying profile of their tumor. Moreover, the infrastructure this study will generate (i.e.: electronic identification of NET patients, entry and completion of tumor table data in PCORnet, and a unique NET patient health record portal), will foster future CER studies in NETs and other rare diseases. The four specific aims of this project are: 1. To describe the frequency of treatment regimens received by line of therapy, and examine their association with symptom burden and changes in 6, 12 and 18 month health-related quality of life (HRQoL) outcomes. The influence of patient preferences, beliefs, attitudes, and experience of care on choice of these treatment regimens will also be examined. 2. To examine the association of patient, clinical, and tumor characteristics on the selection of first-line and beyond treatment regimens and compare the effects of common treatment sequences on frequency of subsequent treatments received and outcomes of overall survival and disease progression. 3. To compare the effectiveness of peptide receptor radionuclide therapy (PRRT) regimens on outcomes of renal toxicity, disease progression, and patient-reported symptoms and HRQoL. 4. To disseminate lessons learned and expand enrollment of the prospective cohort to patient advocate organizations, and to use the infrastructure developed to aid in the study of other rare diseases.

Arms & Interventions


: NET patient observational cohort

Patients diagnosed with lung or gastrointestinal neuroendocrine tumors


Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Florida, Gainesville, Florida



University of Florida

Gainesville, Florida, 32611-5500

University of Iowa, Iowa City, Iowa



University of Iowa

Iowa City, Iowa, 52242

Kansas City, Kansas



University of Kansas Medical Center Research Institute, Inc

Kansas City, Kansas, 66103-2937

Regents of the University of Michigan, Ann Arbor, Michigan



Regents of the University of Michigan

Ann Arbor, Michigan, 48109-1340

Allina Health System, Minneapolis, Minnesota



Allina Health System

Minneapolis, Minnesota, 55407

Mayo Clinic Rochester, Rochester, Minnesota



Mayo Clinic Rochester

Rochester, Minnesota, 55905

Chapel Hill, North Carolina



The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-1350

The Ohio State University, Columbus, Ohio



The Ohio State University

Columbus, Ohio, 43210

University of Pittsburgh, Pittsburgh, Pennsylvania



University of Pittsburgh

Pittsburgh, Pennsylvania, 15260-3203

The Medical University of South Carolina, Charleston, South Carolina



The Medical University of South Carolina

Charleston, South Carolina, 29407-4636

Vanderbilt University Medical Center, Nashville, Tennessee



Vanderbilt University Medical Center

Nashville, Tennessee, 37203

UT Southwestern Medical Center, Dallas, Texas



UT Southwestern Medical Center

Dallas, Texas, 75390-9020

University of Utah, Salt Lake City, Utah



University of Utah

Salt Lake City, Utah, 84112

Medical College of Wisconsin, Inc, Milwaukee, Wisconsin



Medical College of Wisconsin, Inc

Milwaukee, Wisconsin, 53226

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