Clinical trial · Observational
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)
NCT07635316CI-TRIAL-00116822recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (7)
- label
- Overall GEP-NET Cohort
- description
- Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025.
- label
- 1L Lutetium Lu 177 Dotatate Cohort
- description
- A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L lutetium Lu 177 dotatate.
- label
- 1L Capecitabine + Temozolomide (CAPTEM) Cohort
- description
- A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L CAPTEM.
- label
- 1L Cabozantinib Cohort
- description
- A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L cabozantinib.
- label
- Lutetium Lu 177 Dotatate Cohort
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.