NCT07635316Recruiting
A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4023 (estimated)
- First submitted
- 22 May 2026
- Start date
- 12 Jun 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT07635316
What you commit to
- Study type: Observational
- Planned participants: 4023
- From 12 Jun 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with other primary malignancies during the 12-month pre-index period
Age
- Patients with missing or invalid age or sex
Other
- Patients with invalid death date (i.e., death date ≤ index date)
Who the study is looking for
- 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
Age in the registry: 18 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.