EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations

Обзор

This research study is studying a new blood test to screen for Epidermal Growth Factor Receptor (EGFR) positive lung cancer in healthy individuals at risk for the disease and who cannot undergo regular lung cancer screening. The name of the test used in this research study is: -Circulating free DNA (cfDNA) Assay

Подробное описание

The goal of this research study is to evaluate the feasibility of a novel EGFR blood plasma ctDNA screening test among East Asian and Latinx participants at risk for lung cancer and ineligible for regular lung cancer screening. The test looks for a gene change called Epidermal Growth Factor Receptor (EGFR), specifically EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. This study seeks to determine if it is possible to use the blood test to detect this type of lung cancer that might not yet show symptoms.

The research study procedures include screening for eligibility, in-clinic visits, blood tests, and an optional questionnaire and/or focus group.

It is expected that about 1000 people will participate in the blood sample collection, 100 individuals in the survey, and 20 individuals in the focus groups.

Вмешательства

• Устройство Circulating Tumor DNA (ctDNA) Assay
  Screening investigational blood test to test for EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. A positive or indeterminate investigational test will be followed up by CLIA verification of results. A positive or indeterminate CLIA result will be followed up by a lung CT scan. A positive CT scan will be followed up by referral for further evaluation. A negative CT scan will be followed up by a repeat scan in 12 months.

Первичные конечные точки

• Detection Rate of Non-Small Cell Lung Cancer [Срок оценки: 2 years]

Вторичные конечные точки (3)

• Testing Turnaround Time [Срок оценки: Up to 2 years]
• Recruitment Acceptability [Срок оценки: Up to 2 years]
• Barriers to Sample Acquisition [Срок оценки: Up to 2 years]

Критерии участия

Inclusion Criteria (Aims 1, 2, and 3) for Group 1 (50 through 80 years of age):

• Non-tobacco using (currently)
• Self-identify as East Asian (including Southeast Asian) or Hispanic/Latinx.
• East Asian includes those who self-identify as Chinese, Japanese, Korean, Taiwanese, Malaysian
• Southeast Asian includes those who self-identify as Cambodian, Thai, Vietnamese, Filipino
• Latinx includes those who self-identify as a person of Central or South American and the Caribbean including, Cuban, Puerto Rican, and Dominican culture or origin, excluding individuals originating from Spain
• Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean
• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.

Inclusion Criteria (Aims 1, 2, and 3) for Group 2 (40 through 49 years of age):

• Non-tobacco using (currently)
• Self-identify as East Asian (including Southeast Asian) or Latinx, if any of the following criteria are met:

• Family history of EGFR positive LC L858R or exon 19
• Personal history of remote cancer that is not LC or other thoracic malignancies, including thymoma, thymic carcinoma, or sarcoma, as long as it was resolved over 5 years ago
• History of TB, asthma requiring daily inhaled corticosteroids or chronic bronchitis
• Symptoms of lung cancer for the past month, including hemoptysis, unexplained weight loss, voice hoarseness, cough or worsening cough, dyspnea or worsening dyspnea
• Excluding individuals who concurrently present with fever, covid/influenza/RSV/adenovirus infection, runny nose, sore throat, productive cough with green or yellow sputum
• Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean
• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.

Exclusion Criteria (Aims 1, 2, and 3) for Groups 1 and 2:

• Having had a chest CT scan in the last 3 years or having an anticipated chest CT scan during the enrollment period.
• Having a current cancer or history of cancer within the last 5 years, excluding localized non-melanoma skin cancer and breast ductal carcinoma in situ.
• More than 400 lifetime cigarettes (i.e., 20 packs) of smoking or tobacco use
• Adults unable to provide informed consent
• Individuals <40 years of age
• Prisoners
• Pregnant women
• Personal diagnosis of lung cancer
• Not able to be compliant with study requirements

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 6 центров

• Beth Israel Deaconess Medical Center — Boston
• Dana-Farber Cancer Institute — Boston
• Massachusetts General Hospital — Boston
• Dana-Farber Cancer Institute at Steward St. Elizabeth's — Brighton
• Dana-Farber Cancer Instiute Merrimack Valley — Methuen
• Dana-Farber Cancer Institute South Shore — South Weymouth

Идентификаторы

NCT: NCT06716580 · 24-415

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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