Last Update: Jul 06, 2026 

 Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative) 

ClinicalTrials.gov Identifier: [NCT07635316](https://clinicaltrials.gov/ct2/show/NCT07635316)

 

Novartis Reference Number:CAAA601A1US16

 

 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 

 All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

 

##  Study Description 

This study aims to characterize current treatment patterns and clinical outcomes among newly diagnosed GEP-NET patients in the United States using open-source Longitudinal Prescription Claims (LRx) and Patient Centric Medical Claims (Dx) databases supplemented with mortality data.



 

 Condition Gastroenteropancreatic Neuroendocrine Tumor 

 

 Overall Status Recruiting 

 

 Number of Participants4023

 

 

 Start Date Jun 12, 2026 

 

 Completion Date Feb 25, 2027 

 

 Gender All 

 

 Age(s) 18 Years - 110 Years (Adult, Older Adult) 

 

 

 

##  Eligibility Criteria 

Inclusion criteria:

1\. Patients with ≥1 International Classification of Diseases Clinical Modification, 10th revision (ICD-10-CM) diagnosis code for GEP-NET between 01 January 2018 and 31 December 2025. The date of the first such claim will be defined as the diagnosis date.  
2\. Initiation of first-line (1L) systemic therapy (i.e., somatostatin analogs \\\[SSAs\\\], targeted therapy, peptide receptor radionuclide therapy \\\[PRRT\\\], chemotherapy) indicated for GEP-NET on or after the date of diagnosis. The date of treatment initiation will be defined as the index date.  
3\. Patients ≥18 years of age on the index date  
4\. Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:

 1. ≥1 medical and pharmacy claim \\>12 months prior to the index date; AND  
 2. ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND  
 3. ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND  
5\. Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:

 1. ≥ 1 pharmacy dispensing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date  
 2. ≥ 1 provider prescribing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date

Exclusion criteria:

1\. Patients with evidence of GEP-NET prior to the diagnosis date within the study period  
2\. Patients with evidence of GEP-NET treatment prior to the index date within the study period  
3\. Patients with missing or invalid age or sex  
4\. Patients with other primary malignancies during the 12-month pre-index period  
5\. Patients with invalid death date (i.e., death date ≤ index date)



 

 United States 

####  Novartis 

Recruiting

 East Hanover,New Jersey,07936,United States

 

 

 

 

 

 

 

 

 

##  Worldwide Contacts 

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#### Novartis Pharmaceuticals

Phone: [ +41613241111](tel:+41613241111) 

Email: <novartis.email@novartis.com>