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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.

調査の概要

状態

募集

条件

消化器膵臓神経内分泌腫瘍

研究の種類

観察的

入学 (推定)

4023

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Novartis Pharmaceuticals
電話番号：+41613241111
メール：novartis.email@novartis.com

研究連絡先のバックアップ

名前：Novartis Pharmaceuticals

研究場所

アメリカ
- New Jersey
  - East Hanover、New Jersey、アメリカ、07936
    - 募集
    - Novartis

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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. ≥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
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:

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	時間枠
Number of Lines of Therapy (LOTs) 時間枠：Up to approximately 8 years	Up to approximately 8 years
Number and Percentage of Patients by Treatment Regimen per LOT 時間枠：Up to approximately 8 years	Up to approximately 8 years
Number and Percentage of Patients by Type of Therapy in Each LOT 時間枠：Up to approximately 8 years	Up to approximately 8 years
Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen 時間枠：Up to approximately 8 years	Up to approximately 8 years
Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation 時間枠：Up to approximately 8 years	Up to approximately 8 years
Time to 1L Treatment Discontinuation 時間枠：Up to approximately 8 years	Up to approximately 8 years

二次結果の測定

結果測定	メジャーの説明	時間枠
年時間枠：ベースライン		ベースライン
Duration Between GEP-NET Diagnosis and 1L Treatment 時間枠：Baseline		Baseline
Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment 時間枠：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 時間枠：Up to approximately 8 years		Up to approximately 8 years
Time to Next Treatment (TTNT) 時間枠：Up to approximately 8 years		Up to approximately 8 years
Overall Survival (OS) 時間枠：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 時間枠：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 時間枠：Up to approximately 8 years		Up to approximately 8 years
Number and Percentage of Patients by Clinical Characteristics 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

捜査官

スタディディレクター：Novartis Pharmaceuticals、Novartis Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月12日

一次修了 (推定)

2027年2月25日

研究の完了 (推定)

2027年2月25日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物

2026年6月4日

最初の投稿 (実際)

2026年6月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月6日

QC基準を満たした最後の更新が送信されました

2026年7月1日

最終確認日