Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer

Обзор

This is a single-armed screening research study which screens immediate family member of lung cancer patients with a driver mutation to see if lung cancer can be inherited and whether researchers can find lung cancer early. Immediate family members of lung cancer patients will be 40-80 years old and screened using a low dose CT scan.

Вмешательства

• Диагностический тест Low Dose CT Scan
  Completed once after screening and eligibility is confirmed.

Первичные конечные точки

• Number of lung cancers found [Срок оценки: 2 years]

Вторичные конечные точки (6)

• Number of follow-up CT scans [Срок оценки: 2 years]
• Number of lung abnormalities detected [Срок оценки: 2 years]
• Number and type of biopsies performed [Срок оценки: 2 years]
• Number and type of resections performed [Срок оценки: 2 years]
• Number of Adverse Events related to study procedures and follow-up interventions [Срок оценки: 2 years]
• Stage of Lung Cancers Found [Срок оценки: 2 years]

Критерии участия

Cohort A:

Критерии включения

• Current diagnosis of lung cancer with a driver mutation.
• Known driver mutation (e.g. via NGS, PCR, IHC, FISH, RT-PCR etc.)
• Able and willing to give informed consent.
• Able and willing to complete the screening questionnaire.

Cohort A:

Критерии исключения

• There are no exclusion criteria for Cohort A.

Cohort B:

Критерии включения

• Age 40 - 80.
• Must have a first degree relative (mother, father, sibling, biological child) eligible for Cohort A. Note: Multiple first degree relatives of a Cohort A eligible participant may be approached for participation into the trial.
• Smoked < 20 pack years; a. Pack years = numbers of packs per day × number of years smoked; b. One pack year is the equivalent of smoking an average of 20 cigarettes (1 pack) per day for a year.
• Be able to undergo a low dose chest CT scan.
• If an upper respiratory infection (pneumonia, COVID19, flu, etc.) occurred in the last 3 months, this infection must have resolved by time of enrollment.
• Able and willing to provide informed consent.
• Able and willing to comply with the protocol requirements

Cohort B:

Критерии исключения

• Previous history of lung cancers.
• Symptoms suggestive of presence of current lung cancer, including (but not limited to): unexplained weight loss of over 15 pounds within the last 12 months or unexplained hemoptysis.
• Pregnant at time of enrollment.
• History of any type of cancer within 5 years, with the exception of in situ carcinomas and non-melanoma skin cancers (if excised).
• Current smoker.
• Smoked ≥ 20 pack years.
• Had a chest CT scan within 1 year of study entry.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Chao Family Comprehensive Cancer Center University of California, Irvine — Orange

Идентификаторы

NCT: NCT07062172 · 6367 · UCI 24-118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗