Neuroendocrine Tumors Clinical Trial
— NET-PROOfficial title:
A Cohort Study of Symptom Burden and Therapeutic Selection in Neuroendocrine Tumors (NETs)
Verified date | June 2024 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 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.
Status | Enrolling by invitation |
Enrollment | 3010 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 1/1/18, 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 |
Country | Name | City | State |
---|---|---|---|
United States | Regents of the University of Michigan | Ann Arbor | Michigan |
United States | The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | The Medical University of South Carolina | Charleston | South Carolina |
United States | The Ohio State University | Columbus | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | University of Florida | Gainesville | Florida |
United States | University of Iowa | Iowa City | Iowa |
United States | University of Kansas Medical Center Research Institute, Inc | Kansas City | Kansas |
United States | Medical College of Wisconsin, Inc | Milwaukee | Wisconsin |
United States | Allina Health System | Minneapolis | Minnesota |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Iowa | Allina Health System, Healing NET Foundation, Mayo Clinic, Medical College of Wisconsin, Medical University of South Carolina, Neuroendocrine Cancer Awareness Network, Neuroendocrine Tumor Research Foundation, Northern California CarciNET Community, Ohio State University, Patient-Centered Outcomes Research Institute, University of Florida, University of Kansas Medical Center, University of Michigan, University of North Carolina, Chapel Hill, University of Pittsburgh Medical Center, University of Texas Southwestern Medical Center, University of Utah, Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | Renal function | Creatinine clearance loss (per/Yr) | Change in score across baseline, 6, 12, and 18 month time points. | |
Secondary | Norfolk Carcinoid Symptom Score | Patient-reported symptoms | Change in score across baseline, 6, 12, and 18 month time points. | |
Secondary | Experiences with cancer care (from CANCORS) | 13 items to assess cancer care as described at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2953972/ | Change in score across baseline, 6, 12, and 18 month time points. | |
Secondary | Progression-free survival | Time to event | 1-, 3-, and 5-year | |
Secondary | Overall survival | Time to event | Up to 5 years | |
Secondary | Adverse toxicities | Incident acute renal failure, dialysis and liver failure during follow-up | Up to 5 years | |
Secondary | Presence of Acute Renal Failure Diagnosis | Common Data Model (CDM) diagnosis codes for acute renal failure and dialysis | Up to 5 years | |
Secondary | Health related Quality of Life (HRQoL) by PRRT regimen | Changes in HRQOL | Change in score across baseline, 6, 12, and 18 month time points. | |
Secondary | Symptom scores by PRRT regimen | Changes in symptom scores | Change in score across baseline, 6, 12, and 18 month time points. | |
Secondary | Renal toxicity (creatinine clearance) by PRRT isotope | Creatinine clearance loss (per/Yr) 177Lu vs 90Y | Up to 5 years | |
Secondary | Renal toxicity of PRRT by primary tumor location & grade 3 disease | Creatinine clearance loss (per/Yr) GEP-NETs vs lung NETs and G3 | Up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01218555 -
Study of Everolimus (RAD001) in Combination With Lenalidomide
|
Phase 1 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Withdrawn |
NCT04614766 -
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
Completed |
NCT03273712 -
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
|
Phase 2 | |
Recruiting |
NCT05636618 -
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
Completed |
NCT02815969 -
The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
|
||
Completed |
NCT02441062 -
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
|
Phase 2 | |
Active, not recruiting |
NCT02174549 -
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02132468 -
A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers
|
Phase 2 | |
Completed |
NCT02134639 -
PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
|
N/A | |
Recruiting |
NCT01201096 -
Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE)
|
N/A | |
Terminated |
NCT01163526 -
Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
|
N/A | |
Completed |
NCT01099228 -
Combination Targeted Radiotherapy in Neuroendocrine Tumors
|
N/A | |
Completed |
NCT00171873 -
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
|
Phase 3 | |
Active, not recruiting |
NCT05077384 -
Open-label Study of Surufatinib in Japanese Patients
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04544098 -
Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver
|
Early Phase 1 | |
Active, not recruiting |
NCT02736500 -
Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors
|
Phase 1/Phase 2 |