Optimising Screening for Early Disease Detection in Familial Pulmonary Fibrosis (FLORIS)
4 мая 2022 г. обновлено: Jan C. Grutters, MD, St. Antonius Hospital
In this study the prognostic value of the current screening parameters for familial pulmonary fibrosis (FPF) will be investigated by looking at the screenings of 200 first-degree relatives of patients with FPF.
Also insight in the natural history of early FPF, and the necessary interval between screenings visits will be investigated.
Обзор исследования
Статус
Рекрутинг
Подробное описание
Familial pulmonary fibrosis (FPF) is a fatal lung disease that is often not diagnosed until a significant portion of the lung function is lost.
Median survival after diagnosis is 3 to 5 years.
As treatment can only slow down lung function decline, early disease detection is essential to provide timely therapeutic support.
As first-degree relatives of patients with FPF are at high risk of developing pulmonary fibrosis as well, a screening protocol has been put in place.
However, the value of current screening parameters to detect early asymptomatic disease as well as the optimal interval between screening appointments are unknown.
A prospective study into the prognostic value of these screening markers in the target population and the appropriate clinical setting is needed to develop an evidence-based screening protocol.
There will be an emphasis on easily operable parameters that may allow for redirection of (part of the) screening activities to the general practice in the future.
Тип исследования
Наблюдательный
Регистрация (Ожидаемый)
200
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Jan Grutters, Prof.
- Номер телефона: +31883201453
- Электронная почта: j.grutters@antoniusziekenhuis.nl
Учебное резервное копирование контактов
- Имя: Martijn Maus, MD
- Номер телефона: +31883201467
- Электронная почта: m.maus@antoniusziekenhuis.nl
Места учебы
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Nieuwegein, Нидерланды, 3435CM
- Рекрутинг
- St Antonius hospital
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Контакт:
- Jan Grutters, Prof.
- Номер телефона: +31883201453
- Электронная почта: j.grutters@antoniusziekenhuis.nl
-
Контакт:
- Martijn Maus, MD
- Номер телефона: +31883201467
- Электронная почта: m.maus@antoniusziekenhuis.nl
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Asymptomatic first-degree relatives of patients with FPF are invited to enroll.
Описание
Inclusion Criteria:
- Asymptomatic first-degree relative of patients with familial pulmonary fibrosis (FPF)
Exclusion Criteria:
- A previous diagnosis of interstitial lung disease (ILD)
- Minors (aged <18 years)
- Pregnant
Note: woman who are pregnant at the start of the study or at the time of the HRCT are not allowed to participate. If a participant gets pregnant at a later stage during the study, she will not be excluded from the study. To be able to account for a potential effect of pregnancy during data analysis, female participants can be asked if they are pregnant at every visit.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Когорта
- Временные перспективы: Перспективный
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Characteristics of participants
Временное ограничение: Baseline
|
Difference in age, sex, body weight, smoking history and comorbidities between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Forced Vital Capacity (FVC)
Временное ограничение: Baseline
|
Difference in forced vital capacity (FVC) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc)
Временное ограничение: Baseline
|
Difference in haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Total lung capacity (TLC)
Временное ограничение: Baseline
|
Difference in total lung capacity (TLC) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Biomarker levels
Временное ограничение: Baseline
|
Difference in Krebs von den Lungen 6 (KL6), chemokine (C-C motif) ligand 18 (CCL18), surfactant protein-D (SP-D), matrix metalloproteinase 7 (MMP7) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Oxygen saturation in 6-minute walk test (6MWT)
Временное ограничение: Baseline
|
Difference in oxygen saturation (rest in %), oxygen saturation (after 6MWT in %), oxygen saturation (nadir in %) and oxygen saturation (difference between rest and nadir in %) (all continuous variables) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Distance (meters) in 6-minute walk test (6MWT)
Временное ограничение: Baseline
|
Difference in distance covered (in meters) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
MUC5B genotype
Временное ограничение: Baseline
|
Difference in MUC5B genotype (all discrete variables) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Patient reported cough score
Временное ограничение: Baseline
|
Difference in visual analogue scale (VAS) for cough (scores between 0-100, with 100 being the worst) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Patient reported dyspnea score
Временное ограничение: Baseline
|
Difference in medical research council (MRC) (scores between 0-5, with 5 being the worst) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Clubbing
Временное ограничение: Baseline
|
Difference in presence of digital clubbing between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
|
Crackles
Временное ограничение: Baseline
|
Difference in inspiratory crackles during lung auscultation between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Forced Vital Capacity (FVC)
Временное ограничение: 2 years
|
Difference in forced vital capacity (FVC) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc)
Временное ограничение: 2 years
|
Difference in haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Total lung capacity (TLC)
Временное ограничение: 2 years
|
Difference in total lung capacity (TLC) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Biomarker levels
Временное ограничение: 2 years
|
Difference in KL6, CCL18, SP-D and MMP7 over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Genotype
Временное ограничение: 2 years
|
Difference in MUC5B genotype over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Oxygen saturation in 6-minute walk test (6MWT)
Временное ограничение: 2 years
|
Difference in oxygen saturation (rest in %), oxygen saturation (after 6MWT in %), oxygen saturation (nadir in %) and oxygen saturation (difference between rest and nadir in %) (all continuous variables) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Distance (meters) in 6-minute walk test (6MWT)
Временное ограничение: 2 years
|
Difference in distance covered (in meters) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Patient reported cough score
Временное ограничение: 2 years
|
Difference in visual analogue scale (VAS) for cough (scores between 0-100, with 100 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Patient reported dyspnea score
Временное ограничение: 2 years
|
Difference in medical research council (MRC) (scores between 0-5, with 5 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Digital clubbing
Временное ограничение: 2 years
|
Difference in presence of digital clubbing over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Crackles
Временное ограничение: 2 years
|
Difference in inspiratory crackles during lung auscultation over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Patient reported fatigue
Временное ограничение: 2 years
|
Difference in fatigue assessment scale (FAS) (scores range from 10-50, with 50 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
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Patient reported health status
Временное ограничение: 2 years
|
Difference in EuroQol 5D-5L (EQ-5D-5L) (comprises of a score in five levels, level 1-5 with 5 being the worst, and a visual analoque scale ranging from 0-100 with 100 being the best) and the over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Relatedness
Временное ограничение: Baseline
|
In case multiple members of the same family are included in the study
|
Baseline
|
|
Blood count
Временное ограничение: 2 years
|
Blood count (Consisting of; hemoglobin (mmol/l), erythrocytes (x10^12/l), mean corpuscular volume (fl), red cell distribution width (%), thrombocytes (x10^9/l), leukocytes (x10^9/l)) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between bloodcount in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Creatinin
Временное ограничение: 2 years
|
creatinin (umol/l) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between creatinin in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Liver function tests
Временное ограничение: 2 years
|
Liver function tests (consisting of: ASAT (U/l), ALAT (U/l), alkaline phosphatase (U/l), Gamma-glutamyl transpeptidase (U/l)) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between these liver function tests in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Total bilirubin
Временное ограничение: 2 years
|
Total bilirubin (umol/l) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between total bilirubin in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
|
2 years
|
|
Additional blood based markers
Временное ограничение: 2 years
|
Additional blood based markers as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between these blood based markers in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
|
2 years
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
16 июня 2021 г.
Первичное завершение (Ожидаемый)
16 июня 2025 г.
Завершение исследования (Ожидаемый)
1 сентября 2025 г.
Даты регистрации исследования
Первый отправленный
28 марта 2022 г.
Впервые представлено, что соответствует критериям контроля качества
4 мая 2022 г.
Первый опубликованный (Действительный)
10 мая 2022 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 мая 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 мая 2022 г.
Последняя проверка
1 марта 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- NL75303.100.20
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Описание плана IPD
Data of patients is coded
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .