Идёт набор NCT04806412

Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.

Без фазы С лечением Malignant Pleural Effusion Non-small Cell 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: В протоколе указаны: meassurement of PD-L1, ALK, EGFR.
Кому может быть актуально: Состояния в реестре: Malignant Pleural Effusion, Non-small Cell Lung Cancer. Базовые параметры: от 18 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: Дания
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

The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.

Обзор

Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. These can be measured in pleural fluid, but the prevalence is uncertain. In a prospective study, the research team aim to measure PD-L1, ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence. Also, the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up.

Подробное описание

The study is a prospective, non-randomized, cohort study of patients with pleural effusion. Participants will be recruited from patients referred to the Pleura Clinic or admitted at the ward at the Department of Respiratory Medicine, Næstved Hospital, Næstved or at the Department of Respiratory Medicine, Zealand University Hospital, Roskilde, which is the two regional centres for workup of pleural effusions. Patients will be referred from either general practice or other hospital departments.

Pleural fluids with cytology positive for NSCLC will be tested for oncodrivers (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR).

Follow-up will be 8 weeks after inclusion.

Вмешательства

Диагностический тест meassurement of PD-L1, ALK, EGFR
PD-L1 test will be performed on cell-blocks using PD-L1 antibodies 22C3 and staining platform Dako Omnis (Agilent, Glostrup -Denmark). ALK test will be performed on cell-blocks using staining platform Dako Omnis (Agilent, Glostrup- Denmark) and ALK antibodies "Origene" clone: OT1A4. Sample quality is assessed as for PD-L1. EGFR mutation analysis will be performed as follows: after tumor content evaluation of hematoxylin and eosin stained slides, relevant regions are macrodissected and subjecte

Первичные конечные точки

Prevalence of oncodriver status [Срок оценки: assessed at 8 weeks follow-up]

Вторичные конечные точки (12)

Proportion of adequate and inadequate pleural fluid specimens [Срок оценки: assessed at 8-week follow-up]
Amounts of pleural fluid sent for analysis [Срок оценки: assessed at 8-week follow-up]
Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status [Срок оценки: assessed at 8-week follow-up]
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies [Срок оценки: assessed at 8-week follow-up]
Prevalence of oncodriver status in additional diagnostic interventions [Срок оценки: assessed at 8-week follow-up]
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies [Срок оценки: assessed at 8-week follow-up]
- Proportion of work-ups where the lack of obtained oncodriver status in pleural fluid specimens leads to additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies [Срок оценки: assessed at 8-week follow-up]
- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis [Срок оценки: assessed at 8-week follow-up]
- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC. [Срок оценки: assessed at 8-week follow-up]
Patient assessed pain during thoracentesis [Срок оценки: at day 1, 2 minutes after thoracentesis]
Proportion of patients experiencing pneumothorax [Срок оценки: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file]
Proportion of patients experiencing bleeding [Срок оценки: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up]

Критерии участия

Критерии включения

Age ≥ 18 years
Pleural effusion known or suspected of association with NSCLC (pleural fluid cytology positive for cells from NSCLC)
Patients must be able to give informed consent