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Subjects who provide informed consent and meet the eligibility criteria will have 50 ml of blood collected and sent to Freenome or Freenome's designee for processing, testing, and storage, and will then complete a standard-of-care screening LDCT.

blood draw

April Allison, BS

Harris Naemi, BS / Joye Choy, BS

Study Coordinator

Chuanbo Xu, PhD

Nasibeh Vatankhah, MD

The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).

This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer.

Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT.

The study will also collect demographic data and relevant clinical data, such as medical history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan.

All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome Multiomics Blood Test

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 24-month follow-up period

Freenome Holdings Inc.

Low Dose Computed Tomography (LDCT) was performed at baseline + 2 rounds of biennial repeated LDCT. Management of positive screening test will be carried out by a pre-specified protocol.

LDCT was performed at baseline and 2 rounds of biennial repeated LDCT. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm. The management of abnormal nodules including precision diagnosis by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation bronchoscope (ENB) and peripheral biomarkers, and precision therapy by intraoperative frozen section guided lung resection and ENB radiofrequency ablation.

Low Dose Computed Tomography

Baohui Han, MD, PhD

Yanwei Zhang, MD, PhD

Baohui Han, MD,PhD

Yanwei Zhang, MD,PhD

The present study is a single arm clinical trial aiming to improve the key technology in the diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70) are planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening test will be carried out by a pre-specified protocol.

Precision Diagnosis and Therapy for Early Stage Lung Cancer

Key Technology in Precision Diagnosis and Therapy for Early Stage Lung Cancer: a Single Arm Clinical Trial

Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence.

Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.

Assess lung cancer mortality within next 5 years after first round of screening

Shanghai Chest Hospital

: Vice-President

Participants will consist of eligible women who have had a mammogram

MSK developed LungTalk, a novel computer-tailored health communication and decision support tool to (1) increase awareness and knowledge about lung screening; (2) decrease perceived barriers to screening based upon misinformation; and (3) increase screening rates.

LungTalk

Tali Amir, MD

The purpose of this study is to develop a digital strategy to increase awareness about lung cancer screening among women who are eligible to receive it. The digital strategy involves email communications and LungTalk, a web-based (accessed through the Internet) health communication tool that uses text, audio, video, and animation to increase awareness and knowledge about lung cancer screening. This study will focus on women who have recently received a screening mammogram.

A Study to Develop a Strategy to Increase Lung Cancer Screening in Women Who May Be at Risk for Lung Cancer

Leveraging Mammography to Identify and Engage Women at Risk for Lung Cancer in Lung Cancer Screening

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Develop a proactive digital outreach and engagement strategy to identify breast screening patients who are eligible for lung screening.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening	NCT06122077	Lung Cancer Dia...	blood draw	50 Years -	Freenome Holdings Inc.
Precision Diagnosis and Therapy for Early Stage Lung Cancer	NCT02936804	Lung Cancer	Low Dose Comput...	45 Years - 70 Years	Shanghai Chest Hospital
A Study to Develop a Strategy to Increase Lung Cancer Screening in Women Who May Be at Risk for Lung Cancer	NCT04848961	Smoking	LungTalk	50 Years - 80 Years	Memorial Sloan Kettering Cancer Center
Precision Diagnosis and Therapy for Early Stage Lung Cancer	NCT02936804	Lung Cancer	Low Dose Comput...	45 Years - 70 Years	Shanghai Chest Hospital
A Study to Develop a Strategy to Increase Lung Cancer Screening in Women Who May Be at Risk for Lung Cancer	NCT04848961	Smoking	LungTalk	50 Years - 80 Years	Memorial Sloan Kettering Cancer Center
Precision Diagnosis and Therapy for Early Stage Lung Cancer	NCT02936804	Lung Cancer	Low Dose Comput...	45 Years - 70 Years	Shanghai Chest Hospital
Precision Diagnosis and Therapy for Early Stage Lung Cancer	NCT02936804	Lung Cancer	Low Dose Comput...	45 Years - 70 Years	Shanghai Chest Hospital

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