- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07635316
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)
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Novartis Pharmaceuticals
- Número de telefone: +41613241111
- E-mail: novartis.email@novartis.com
Estude backup de contato
- Nome: Novartis Pharmaceuticals
Locais de estudo
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New Jersey
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East Hanover, New Jersey, Estados Unidos, 07936
- Recrutamento
- Novartis
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Number of Lines of Therapy (LOTs)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to approximately 8 years
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Up to approximately 8 years
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Time to 1L Treatment Discontinuation
Prazo: Up to approximately 8 years
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Up to approximately 8 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Era
Prazo: Linha de base
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Linha de base
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Duration Between GEP-NET Diagnosis and 1L Treatment
Prazo: 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
Prazo: 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
Prazo: Up to approximately 8 years
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Up to approximately 8 years
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Time to Next Treatment (TTNT)
Prazo: Up to approximately 8 years
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Up to approximately 8 years
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Overall Survival (OS)
Prazo: 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
Prazo: Baseline
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Demographics include:
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Baseline
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Duration of Follow-up
Prazo: 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
Prazo: Baseline
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Clinical characteristics include:
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Baseline
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NCI Comorbidity Index Score
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CAAA601A1US16
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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