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Идёт набор NCT05384769

Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer

Без фазы С лечением Lung Carcinoma

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: Liquid Biopsy, Low Dose Computed Tomography of the Chest, Survey Administration.
Кому может быть актуально
Состояния в реестре: Lung Carcinoma. 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
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Официальное название

Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers

Обзор

This clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (DNA) liquid biopsy is in screening high-risk patients for lung cancer. Currently, a low dose computed tomography (CT) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. Liquid biopsy utilizes technology that can detect small amounts of DNA shed by cancer cells and may be able to spot lung cancer at an earlier stage. If a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose CT (LDCT) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine the feasibility of lung cancer screening using liquid biopsy in a community setting.

SECONDARY OBJECTIVES:

I. To determine screening follow-through rates in those who agreed to undergo screening by preferred modality (liquid biopsy versus \[vs\] LDCT).

II. To determine the rate of LDCT following liquid biopsy (in those who underwent liquid biopsy) after stratifying by test result (negative versus positive).

III. To compare participant sociodemographic factors (age, sex, race/ethnicity, educational background) and survey scores across screening preference (liquid biopsy vs. LDCT).

OUTLINE: Participants choose 1 of 2 cohorts.

COHORT A: Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive.

COHORT B: Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.

After completion of study, patients are followed up at 6 months.

Вмешательства

  • Процедура Liquid Biopsy
    Undergo liquid biopsy
  • Процедура Low Dose Computed Tomography of the Chest
    Undergo low dose CT
  • Другое Survey Administration
    Ancillary studies

Первичные конечные точки

  • Screening preference [Срок оценки: Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.]
Вторичные конечные точки (11)
  • Participants who follow-through on screening 1 [Срок оценки: 6 month follow-up timepoint.]
  • Participants who follow-through on screening 2 [Срок оценки: 6 month follow-up timepoint.]
  • Participants who follow-through on screening 3 [Срок оценки: 6 month follow-up timepoint.]
  • Participants who follow-through on screening 4 [Срок оценки: 6 month follow-up timepoint.]
  • Participants who undergo low dose computed tomography of the chest (LDCT) after receiving liquid biopsy results [Срок оценки: Up to 6 months]
  • Sociodemographic factors (age, sex, race/ethnicity, educational background) [Срок оценки: At baseline visit]
  • Survey scores across screening preference 1 [Срок оценки: At 6 month follow up]
  • Survey scores across screening preference 2 [Срок оценки: At 6 month follow up]
  • Survey scores across screening preference 3 [Срок оценки: At 6 month follow up]
  • Survey scores across screening preference 4 [Срок оценки: At 6 month follow up]
  • Survey scores across screening preference 5 [Срок оценки: At 6 month follow up]

Критерии участия

Критерии включения

  • Documented written informed consent of the participant.
  • Age 50-80 years.
  • Smoking history of >= 20 pack-years and if quit, quit within 15 years.
  • Received referral for counseling for lung cancer screening and would qualify for LDCT.
  • Health Insurance that will pay for a LDCT for lung cancer screening at either City of Hope Duarte, Newport Beach (Newport Diagnostic Imaging), or Lancaster (Renaissance Imaging/Antelope Valley Outpatient Imaging Center).
  • Willingness to provide blood sample.
  • English speaking.
  • Consent to undergo lung cancer screening with either liquid biopsy (LB) or LDCT.

Критерии исключения

  • Symptoms of lung cancer.
  • Chest CT scan or chest positron emission tomography (PET)/CT within 12 months.
  • Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer.
  • Unable to undergo LDCT at either City of Hope Duarte, Newport Beach, or Lancaster.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT05384769 · 21591 · NCI-2022-02513 · 21591 · P30CA033572

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗