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

2026년 7월 1일 업데이트: 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.

연구 개요

상태

모병

정황

위장췌장 신경내분비종양

연구 유형

관찰

등록 (추정된)

4023

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Novartis Pharmaceuticals
전화번호: +41613241111
이메일: novartis.email@novartis.com

연구 연락처 백업

이름: Novartis Pharmaceuticals

연구 장소

미국
- New Jersey
  - East Hanover, New Jersey, 미국, 07936
    - 모병
    - Novartis

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

결과 측정	측정값 설명	기간
나이 기간: 기준선		기준선
Duration Between GEP-NET Diagnosis and 1L Treatment 기간: Baseline		Baseline
Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment 기간: 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 기간: Up to approximately 8 years		Up to approximately 8 years
Time to Next Treatment (TTNT) 기간: Up to approximately 8 years		Up to approximately 8 years
Overall Survival (OS) 기간: 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 기간: 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 기간: Up to approximately 8 years		Up to approximately 8 years
Number and Percentage of Patients by Clinical Characteristics 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

수사관

연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 12일

기본 완료 (추정된)

2027년 2월 25일

연구 완료 (추정된)

2027년 2월 25일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 1일

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