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Recruiting NCT07635316

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

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Sex: All
Ages: 18 Years – 110 Years
Healthy volunteers: No
Enrollment: 4023
Sponsor: Novartis Pharmaceuticals

Location: Novartis East Hanover New Jersey

Summary

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.

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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07635316). StuddyBuddy aggregates publicly available trial information.