GEP-NET treatment patterns and outcomes in the U.S.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses open-source prescription and medical claims databases, plus mortality data, to describe treatment patterns and outcomes after diagnosis of GEP-NET in the United States. It includes patients 18 and older who begin first-line systemic therapy after diagnosis and have at least 12 months of data prior to treatment. The analysis will focus on real-world practices across somatostatin analogs, targeted therapies, PRRT, and chemotherapy, along with survival and other outcomes. The study is sponsored by Novartis and conducted with data partner sources in the U.S.

Why it matters

Who can join: the full rules

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)

Where it's running

• Novartis
  East Hanover, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.