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Набор скоро начнётся NCT06484972

A Study to Evaluate Guideline Adoption Through Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department

— Наблюдательное Lung Cancer

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: Lung Cancer. Базовые параметры: Без ограничений · 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
Список центров уточняется — проверьте первичный протокол.
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

A Multicenter Cluster Randomized Controlled Study to Evaluate Guideline Adoption Through Lung Cancer Clinical Care Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department

Обзор

This is a cluster randomized controlled trial with PCCM department in each site being the cluster. Fifty-four sites' PCCM departments will be randomized to the QIP arm versus control arm in 2:1 allocation ratio. The QIP arm will perform QIP intervention. The control arm will not receive intervention and continue with usual care. The primary endpoints of this study are molecular testing rate of non-small cell lung cancer (NSCLC) prior to the first systematic anti-tumor therapy, and adjuvant or first line targeted therapy treatment rate in actionable oncogenic alterations (AGA) NSCLC.

Подробное описание

Approximately 1728 patients from 54 sites will be enrolled (about 30 NSCLC \[20%-30% squamous cases\] and 2 extensive-stage small-cell lung cancer \[ES-SCLC\] patients in each site). Patients in the QIP arm will be enrolled after about 3-month QIP intervention. Patients in the control arm will be enrolled as soon as the trial starts. Data on lung cancer diagnosis and treatment pattern will be collected.

Первичные конечные точки

  • Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • Adjuvant or first line targeted therapy treatment rate in AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
Вторичные конечные точки (12)
  • TNM stage diagnosis rate prior to the first anti-tumor therapy [Срок оценки: Baseline]
  • Biopsy method [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • Spirometry rate [Срок оценки: Baseline]
  • First line immunotherapy treatment rate in unresectable non-AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • First line chemotherapy-immunotherapy treatment rate of ES-SCLC(Extensive-stage small-cell lung cancer) (stage III-IV) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer) [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]
  • DFS(Disease free survival) of NSCLC(Non-small cell lung cancer) who receive neoadjuvant/adjuvant therapy [Срок оценки: Baseline, 3/6/12/21/30 months post enrollment]

Критерии участия

  • Cluster 1.1 Cluster inclusion criteria 1.1.1 PCCM department in Tier 3 hospital. 1.1.2 PCCM department's standardized construction certification is "qualified ".

1.1.3 PCCM department who want to improve lung cancer healthcare quality and agree to participate in study.

1.2 Cluster exclusion criteria 1.2.1 PCCM department does not carry out anti-tumor treatment for lung cancer. 1.2.2 PCCM department participant in other lung cancer quality improvement study.

  • Individual Patient 2.1 Individual inclusion criteria 2.1.1 Pathology diagnosed NSCLC or ES-SCLC. 2.1.2 No prior systematic anti-tumor therapy, or prior adjuvant and neo-adjuvant therapies, definitive radiation/chemoradiation are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.

2.1.3 Performance score (PS) 0-2. 2.1.4 Life expectancy >12 weeks. 2.2 Individual exclusion criteria 2.2.1 Have a plan to transfer to other hospitals to receive anti-tumor therapy within 3 months after signing the ICF.

2.2.2 Participating in another interventional clinical study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06484972 · ESR-24-22776

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗