A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
1 juillet 2026 mis à jour par: Novartis Pharmaceuticals
Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Observationnel
Inscription (Estimé)
4023
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Novartis Pharmaceuticals
- Numéro de téléphone: +41613241111
- E-mail: novartis.email@novartis.com
Sauvegarde des contacts de l'étude
- Nom: Novartis Pharmaceuticals
Lieux d'étude
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New Jersey
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East Hanover, New Jersey, États-Unis, 07936
- Recrutement
- Novartis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients with evidence of a GEP-NET diagnosis between 01 January 2018 and 31 December 2025 and initiating a 1L treatment during this time period.
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Overall GEP-NET Cohort
Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025.
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1L Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving 1L lutetium Lu 177 dotatate.
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1L Capecitabine + Temozolomide (CAPTEM) Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving 1L CAPTEM.
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1L Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving 1L cabozantinib.
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Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving lutetium Lu 177 dotatate in 2L or later settings.
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CAPTEM Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving CAPTEM in 2L or later settings.
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Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving cabozantinib in 2L or later settings.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Number of Lines of Therapy (LOTs)
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Number and Percentage of Patients by Treatment Regimen per LOT
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Number and Percentage of Patients by Type of Therapy in Each LOT
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Time to 1L Treatment Discontinuation
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Âge
Délai: Ligne de base
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Ligne de base
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Duration Between GEP-NET Diagnosis and 1L Treatment
Délai: Baseline
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Baseline
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Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Time to Next Treatment (TTNT)
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Overall Survival (OS)
Délai: Up to approximately 8 years
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OS calculated as the number of weeks from the start of treatment until death.
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Up to approximately 8 years
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Number and Percentage of Patients by Demographics
Délai: Baseline
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Demographics include:
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Baseline
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Duration of Follow-up
Délai: Up to approximately 8 years
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Up to approximately 8 years
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Number and Percentage of Patients by Clinical Characteristics
Délai: Baseline
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Clinical characteristics include:
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Baseline
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NCI Comorbidity Index Score
Délai: Baseline
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The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions.
It includes 14 conditions identified using administrative data diagnosis and procedure codes.
The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions.
Each condition is assigned a score (from 1 to 6) based on how serious it is and patient scores are summed to give a final overall score.
A high score indicates a higher burden of comorbid conditions and possible higher risk of death.
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Baseline
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 juin 2026
Achèvement primaire (Estimé)
25 février 2027
Achèvement de l'étude (Estimé)
25 février 2027
Dates d'inscription aux études
Première soumission
22 mai 2026
Première soumission répondant aux critères de contrôle qualité
4 juin 2026
Première publication (Réel)
9 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAAA601A1US16
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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