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A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

2026年7月1日 更新者：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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

4023

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Novartis Pharmaceuticals

学习地点

  • 美国
    • New Jersey
      • East Hanover、New Jersey、美国、07936
        • 招聘中
        • Novartis

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Overall GEP-NET Cohort
Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025.
1L Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L lutetium Lu 177 dotatate.
1L Capecitabine + Temozolomide (CAPTEM) Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L CAPTEM.
1L Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L cabozantinib.
Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving lutetium Lu 177 dotatate in 2L or later settings.
CAPTEM Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving CAPTEM in 2L or later settings.
Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving cabozantinib in 2L or later settings.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of Lines of Therapy (LOTs)
大体时间：Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients by Treatment Regimen per LOT
大体时间：Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients by Type of Therapy in Each LOT
大体时间：Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen
大体时间：Up to approximately 8 years
Up to approximately 8 years
Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation
大体时间：Up to approximately 8 years
Up to approximately 8 years
Time to 1L Treatment Discontinuation
大体时间：Up to approximately 8 years
Up to approximately 8 years

次要结果测量

结果测量
措施说明
大体时间
年龄
大体时间：基线
基线
Duration Between GEP-NET Diagnosis and 1L Treatment
大体时间：Baseline
Baseline
Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment
大体时间：Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy
大体时间：Up to approximately 8 years
Up to approximately 8 years
Time to Next Treatment (TTNT)
大体时间：Up to approximately 8 years
Up to approximately 8 years
Overall Survival (OS)
大体时间：Up to approximately 8 years
OS calculated as the number of weeks from the start of treatment until death.
Up to approximately 8 years
Number and Percentage of Patients by Demographics
大体时间：Baseline

Demographics include:

  • Age group (18-34, 35-44, 45-54, 55-64, 65+ years)
  • Sex
  • Geographic region
  • Payer type
  • Race/ethnicity
  • Education level
  • Occupation
  • Marital status
Baseline
Duration of Follow-up
大体时间：Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients by Clinical Characteristics
大体时间：Baseline

Clinical characteristics include:

  • National Cancer Institute (NCI) comorbidity index category (0, 1, 2, 3+)
  • Comorbidities
  • Treating provider specialty
  • Metastatic sites (bone, visceral, lymph node, liver)
  • Number of distinct metastatic sites (0, 1, 2, 3, 4+)
Baseline
NCI Comorbidity Index Score
大体时间：Baseline
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.
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

调查人员

  • 研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月12日

初级完成 (估计的)

2027年2月25日

研究完成 (估计的)

2027年2月25日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月1日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CAAA601A1US16

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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