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Идёт набор NCT07635316

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

— Наблюдательное Gastroenteropancreatic Neuroendocrine Tumor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Gastroenteropancreatic Neuroendocrine Tumor. Базовые параметры: 18 лет — 110 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)

Обзор

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.

Первичные конечные точки

  • Number of Lines of Therapy (LOTs) [Срок оценки: Up to approximately 8 years]
  • Number and Percentage of Patients by Treatment Regimen per LOT [Срок оценки: Up to approximately 8 years]
  • Number and Percentage of Patients by Type of Therapy in Each LOT [Срок оценки: Up to approximately 8 years]
  • Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen [Срок оценки: Up to approximately 8 years]
  • Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation [Срок оценки: Up to approximately 8 years]
  • Time to 1L Treatment Discontinuation [Срок оценки: Up to approximately 8 years]
Вторичные конечные точки (10)
  • Duration Between GEP-NET Diagnosis and 1L Treatment [Срок оценки: Baseline]
  • Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment [Срок оценки: Up to approximately 8 years]
  • Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy [Срок оценки: Up to approximately 8 years]
  • Time to Next Treatment (TTNT) [Срок оценки: Up to approximately 8 years]
  • Overall Survival (OS) [Срок оценки: Up to approximately 8 years]
  • Number and Percentage of Patients by Demographics [Срок оценки: Baseline]
  • Age [Срок оценки: Baseline]
  • Duration of Follow-up [Срок оценки: Up to approximately 8 years]
  • Number and Percentage of Patients by Clinical Characteristics [Срок оценки: Baseline]
  • NCI Comorbidity Index Score [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Novartis — East Hanover

Идентификаторы

NCT: NCT07635316 · CAAA601A1US16

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗