Neuroendocrine TumorsNET-PRONCT05064150
Neuroendocrine Tumors - Patient Reported Outcomes
An observational study of Neuroendocrine Tumors and Gastroenteropancreatic Neuroendocrine Tumor, run by University of Iowa at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor, Lung Neuroendocrine Neoplasm
- How many people
- 2,539 participants
- Where
- 14 sitesUnited States
- Study dates
- 10 May 2022to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Regents of the University of Michigan
Ann Arbor, Michigan, 48109-1340
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1350
The Medical University of South Carolina
Charleston, South Carolina, 29407-4636
The Ohio State University
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390-9020
University of Florida
Gainesville, Florida, 32611-5500
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas, 66103-2937
Medical College of Wisconsin, Inc
Milwaukee, Wisconsin, 53226
Allina Health System
Minneapolis, Minnesota, 55407
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260-3203
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Cohort Study of Symptom Burden and Therapeutic Selection in Neuroendocrine Tumors (NETs)
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.
Read the detailed description
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:
- 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.
- 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.
- To compare the effectiveness of peptide receptor radionuclide therapy (PRRT) regimens on outcomes of renal toxicity, disease progression, and patient-reported symptoms and HRQoL.
- 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.
- Conditions
- Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor, Lung Neuroendocrine Neoplasm, Neuroendocrine Carcinoma
- Keywords
- Patient-reported outcomes, Neuroendocrine, Quality of Life, Survival, Treatment sequencing, Symptom burden
- Medical subject headings
- Neuroendocrine Tumors, Gastro-enteropancreatic neuroendocrine tumor, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NET patient observational cohort | Patients diagnosed with lung or gastrointestinal neuroendocrine tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Up to 5 years
Renal function
Creatinine clearance loss (per/Yr)
Measured: Change in score across baseline, 6, 12, and 18 month time points.
Secondary outcomes (10)
Norfolk Carcinoid Symptom Score
Patient-reported symptoms
Measured: Change in score across baseline, 6, 12, and 18 month time points.
Experiences with cancer care (from CANCORS)
13 items to assess cancer care as described at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2953972/
Measured: Change in score across baseline, 6, 12, and 18 month time points.
Progression-free survival
Time to event
Measured: 1-, 3-, and 5-year
Overall survival
Time to event
Measured: Up to 5 years
Adverse toxicities
Incident acute renal failure, dialysis and liver failure during follow-up
Measured: Up to 5 years
Presence of Acute Renal Failure Diagnosis
Common Data Model (CDM) diagnosis codes for acute renal failure and dialysis
Measured: Up to 5 years
Health related Quality of Life (HRQoL) by PRRT regimen
Changes in HRQOL
Measured: Change in score across baseline, 6, 12, and 18 month time points.
Symptom scores by PRRT regimen
Changes in symptom scores
Measured: Change in score across baseline, 6, 12, and 18 month time points.
Renal toxicity (creatinine clearance) by PRRT isotope
Creatinine clearance loss (per/Yr) 177Lu vs 90Y
Measured: Up to 5 years
Renal toxicity of PRRT by primary tumor location & grade 3 disease
Creatinine clearance loss (per/Yr) GEP-NETs vs lung NETs and G3
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start10 May 2022
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Allina Health System, Medical College of Wisconsin, University of Kansas Medical Center, University of Texas Southwestern Medical Center, University of Utah, University of Florida, Ohio State University, University of Michigan, University of Pittsburgh Medical Center, Medical University of South Carolina, University of North Carolina, Chapel Hill, Vanderbilt University Medical Center, Mayo Clinic, Northern California CarciNET Community, Neuroendocrine Cancer Awareness Network, Neuroendocrine Tumor Research Foundation, Healing NET Foundation, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Michael A O'Rorke, University of Iowa
- Investigators
- Michael O'Rorke, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064150
- Sponsor's protocol ID
- 202104599
- Acronym
- NET-PRO
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available to researchers and details will be provided.
Publications
O'Rorke MA, McDowell BD, Xu T, DeCook RR, Gryzlak BM, Rudzianski NJ, Serrano KC, Wehrheim AM, Grewal US, Chandrasekharan C, Dillon JS, Halfdanarson TR, Schnell MJ, Witter CL, Gamblin TC, Kazmi S, Cowell LG, Else T, Soares HP, Sukrithan V, Chandaka S, Sanoff HK, He FC, Geller DA, Ramirez RA, Liu M, Lancaster W, Mailman JA, Moran H, Wahmann M, Gellerman E, Chrischilles EA. Assessing Patient Characteristics in Neuroendocrine Tumor Research: A Comparison of the NET-PRO Study to SEER Population-Based Data. Endocrine. 2026 Apr 27;91(1):141. doi: 10.1007/s12020-026-04611-w.
PubMed 42043735
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Symptom Burden and Therapeutic Selection in Neuroendocrine Tumors (NETs)
- ClinicalTrials.gov ID
- NCT05064150
- Acronym / sponsor ID
- NET-PRO / 202104599
- Conditions
- Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor, Lung Neuroendocrine Neoplasm, Neuroendocrine Carcinoma
- Keywords
- Patient-reported outcomes, Neuroendocrine, Quality of Life, Survival, Treatment sequencing, Symptom burden
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,539 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Allina Health System, Medical College of Wisconsin, University of Kansas Medical Center, University of Texas Southwestern Medical Center, University of Utah, University of Florida, Ohio State University, University of Michigan, University of Pittsburgh Medical Center, Medical University of South Carolina, University of North Carolina, Chapel Hill, Vanderbilt University Medical Center, Mayo Clinic, Northern California CarciNET Community, Neuroendocrine Cancer Awareness Network, Neuroendocrine Tumor Research Foundation, Healing NET Foundation, Patient-Centered Outcomes Research Institute
- Study start
- 10 May 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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.
- To compare the effectiveness of peptide receptor radionuclide therapy (PRRT) regimens on outcomes of renal toxicity, disease progression, and patient-reported symptoms and HRQoL.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NET patient observational cohort | – | –Patients diagnosed with lung or gastrointestinal neuroendocrine tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Change in score across baseline, 6, 12, and 18 month time points.
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.
European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GI.NET21)
Time frame: Change in score across baseline, 6, 12, and 18 month time points.
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.
Sequencing of treatment regimens from electronic medical records (% of patients using modality)
Time frame: Up to 5 years
Ordering of treatment receipt i.e.: first-line, 2nd line 3rd line therapies
Renal function
Time frame: Change in score across baseline, 6, 12, and 18 month time points.
Creatinine clearance loss (per/Yr)
10 secondary outcomes
Norfolk Carcinoid Symptom Score
Time frame: Change in score across baseline, 6, 12, and 18 month time points.
Experiences with cancer care (from CANCORS)
Time frame: Change in score across baseline, 6, 12, and 18 month time points.
Progression-free survival
Time frame: 1-, 3-, and 5-year
Overall survival
Time frame: Up to 5 years
Adverse toxicities
Time frame: Up to 5 years
Presence of Acute Renal Failure Diagnosis
Time frame: Up to 5 years
Health related Quality of Life (HRQoL) by PRRT regimen
Time frame: Change in score across baseline, 6, 12, and 18 month time points.
Symptom scores by PRRT regimen
Time frame: Change in score across baseline, 6, 12, and 18 month time points.
Renal toxicity (creatinine clearance) by PRRT isotope
Time frame: Up to 5 years
Renal toxicity of PRRT by primary tumor location & grade 3 disease
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42043735O'Rorke MA, McDowell BD, Xu T, DeCook RR, Gryzlak BM, Rudzianski NJ, Serrano KC, Wehrheim AM, Grewal US, Chandrasekharan C, Dillon JS, Halfdanarson TR, Schnell MJ, Witter CL, Gamblin TC, Kazmi S, Cowell LG, Else T, Soares HP, Sukrithan V, Chandaka S, Sanoff HK, He FC, Geller DA, Ramirez RA, Liu M, Lancaster W, Mailman JA, Moran H, Wahmann M, Gellerman E, Chrischilles EA. Assessing Patient Characteristics in Neuroendocrine Tumor Research: A Comparison of the NET-PRO Study to SEER Population-Based Data. Endocrine. 2026 Apr 27;91(1):141. doi: 10.1007/s12020-026-04611-w.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available to researchers and details will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael O'Rorke, PhD principal investigator
University of Iowa
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Gastroenteropancreatic Neuroendocrine Tumor, run by University of Iowa at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) (time frame: Change in score across baseline, 6, 12, and 18 month time points.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.