Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,023
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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)
研究组 & 干预措施
1L Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L lutetium Lu 177 dotatate.
Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving cabozantinib in 2L or later settings.
Overall GEP-NET Cohort
Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025.
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.
1L Capecitabine + Temozolomide (CAPTEM) Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L CAPTEM.