Clinical trial · Observational
Neuroendocrine Tumors - Patient Reported Outcomes
A Cohort Study of Symptom Burden and Therapeutic Selection in Neuroendocrine Tumors (NETs)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
| Lung Neuroendocrine Neoplasm | Lung Neuroendocrine Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- NET patient observational cohort
- description
- Patients diagnosed with lung or gastrointestinal neuroendocrine tumors
Primary outcomes (4)
- measure
- European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
- timeFrame
- Change in score across baseline, 6, 12, and 18 month time points.
- description
- 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.
- measure
- European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GI.NET21)
- timeFrame
- Change in score across baseline, 6, 12, and 18 month time points.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * (1) Adults age 18 years or older at time of NET diagnosis * (2) Diagnosis of GEP-NET or lung NET between 1/1/2018 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. Exclusion Criteria: 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
References
Publications (1)
- DERIVEDO'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. PMID 42043735