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Идёт набор NCT07482475

University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2

— Наблюдательное COPD (Chronic Obstructive Pulmonary Disease) Cancer Lung Screening Smoking Cigarette

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: COPD (Chronic Obstructive Pulmonary Disease), Cancer Lung Screening, Smoking Cigarette. Базовые параметры: 50 лет — 80 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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Обзор

The purpose of this study is to obtain new knowledge regarding screening for COPD. This study will use a participant's cancer screening CT scans performed as part of routine health care among current and former smokers at risk for COPD to identify participants who have had a spirometry or will have a spirometry test as part of the study to verify COPD status.

Первичные конечные точки

  • Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD [Срок оценки: Baseline]
Вторичные конечные точки (3)
  • Lung Attenuation Area (LAA) Thresholds [Срок оценки: Baseline]
  • Exacerbation risk and symptom burden [Срок оценки: Baseline]
  • Severity of COPD [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Eligible for lung cancer screening by USPSTF 2021 criteria including age 50-80 years and currently or formerly smoking with at last 20 pack-years of smoking history at the time of consent.
  • Willingness to participate in an observational clinical trial and to be contacted about future ancillary studies that could include interventional clinical trials.
  • Ability to tolerate study procedures.
  • Ability to provide informed consent.
  • Clinical Lung Cancer Screening CT performed at the University of Michigan within the last year
  • Meets one of the three following criteria:
  • Prior Diagnosis of COPD in the EMR
  • Prior pulmonary function meeting criteria for COPD (FEV1/FVC ≤ 0.70) or
  • LAA>1% on lung cancer screening CT scan

Критерии исключения

  • The presence of a respiratory condition other than COPD or asthma, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g. dyspnea or decreased exercise tolerance).
  • Severe asthma, which is defined as any of the following:

Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; Medium dose = >250 fluticasone propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). The investigators will accept low-dose ICS/LABA or medium dose ICS.

or 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months or One asthma hospitalization in the past 12 months

  • Concurrent participation in a therapeutic trial where treatment is blinded.
  • Active pregnancy. Documentation of birth control will be required for pre-menopausal women.
  • Cognitive dysfunction that prevents the participant from completing study procedures.
  • BMI > 35 kg/m2 at baseline, due to the effects of body weight on CT scan quality.
  • Current illicit substance abuse, including cannabis smoking.
  • Any illness expected to cause mortality in the next 3 years.
  • Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan quality.
  • History of thoracic radiation or thoracic surgery with resection of lung tissue.

Additional temporal exclusion criteria are as follows:

  • Participants who present with an acute exacerbation of COPD, either solely participant-identified or that has been clinically treated, in the last 30 days can be rescreened for the study once the 30-day window from end of drug therapy has passed.
  • Participants who present with current use of acute antibiotics or steroids can be rescreened for the study ≥30 days after discontinuing acute antibiotics/steroids. This restriction does not apply to participants who are on chronic prednisone therapy of <10 mg per day or <20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.

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
  • University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07482475 · HUM00271924

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗