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Recruiting NCT07635316

A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

— Observational Gastroenteropancreatic Neuroendocrine Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gastroenteropancreatic Neuroendocrine Tumor. Basic parameters: 18 years — 110 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Number of Lines of Therapy (LOTs) [Time frame: Up to approximately 8 years]
  • Number and Percentage of Patients by Treatment Regimen per LOT [Time frame: Up to approximately 8 years]
  • Number and Percentage of Patients by Type of Therapy in Each LOT [Time frame: Up to approximately 8 years]
  • Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen [Time frame: Up to approximately 8 years]
  • Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation [Time frame: Up to approximately 8 years]
  • Time to 1L Treatment Discontinuation [Time frame: Up to approximately 8 years]
Secondary outcome measures (10)
  • Duration Between GEP-NET Diagnosis and 1L Treatment [Time frame: Baseline]
  • Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment [Time frame: Up to approximately 8 years]
  • Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy [Time frame: Up to approximately 8 years]
  • Time to Next Treatment (TTNT) [Time frame: Up to approximately 8 years]
  • Overall Survival (OS) [Time frame: Up to approximately 8 years]
  • Number and Percentage of Patients by Demographics [Time frame: Baseline]
  • Age [Time frame: Baseline]
  • Duration of Follow-up [Time frame: Up to approximately 8 years]
  • Number and Percentage of Patients by Clinical Characteristics [Time frame: Baseline]
  • NCI Comorbidity Index Score [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.
  • Patients ≥18 years of age on the index date
  • Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:
  • ≥1 medical and pharmacy claim >12 months prior to the index date; AND
  • ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND
  • ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND
  • Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:
  • ≥ 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
  • ≥ 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Novartis — East Hanover

Identifiers

NCT: NCT07635316 · CAAA601A1US16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗