A new study to evaluate the accuracy of a blood test for detecting lung cancer in high-risk adults has enrolled its first participant with plans to enroll thousands more.
A study to evaluate the accuracy of a blood test to detect lung cancer in high-risk adults aged 50 to 80 years has begun enrollment, according to a press release from Guardant Health, Inc.
The screening for high-frequency malignant disease (SHIELD) LUNG study is a prospective, registrational study that plans to examine 10,000 patients across 100 centers in the United States and Europe.
Researchers will evaluate the sensitivity and specificity of the blood-based test — GuardantLUNAR-2 — to see whether it can detect high frequency cancer.
“Symptoms of lung cancer don’t appear until the disease is already at an advanced stage. That’s why it’s so important to find lung cancer early, before symptoms start,” said Dr. Craig Eagle, Guardant Health chief medical officer, in the release. “Unfortunately, many people do not follow recommended screening guidelines for lung cancer. We believe a simple blood test could help improve screening rates and detect lung cancer early, when it can most easily be treated.”
The current recommendation for lung cancer screenings from the U.S. Preventive Services Task Force is for people ages 50 to 80 years at high risk for lung cancer (due to smoking history but without signs or symptoms) to get a yearly screening via a CT scan. However, only 14% of eligible individuals are up to date with the recommendations, despite the fact that lung cancer is currently the leading cause of cancer-related death.
Researchers working on the SHIELD study plan to separate participants into cancer-risk groups with specified pathways for cancer screening. Participants will have blood drawn and fill out questionnaires within 90 days of standard of care screening method and prior to any invasive procedure for cancer diagnosis or treatment. They plan to follow up with the patients once each year after blood draw for two years, with possible additional follow-up depending on the patient group.
Researchers plan to complete the study in December 2025. Patients may be eligible if they are aged between 50 to 80 years old and have an increased risk of lung cancer (a 20 pack-year smoking history and currently smoke or have quit within the past 15 years).
“Lung cancer screening is known to save lives,” said Guardiant Health’s co-CEO AmirAli Talasaz. “This study will add to the growing body of evidence that supports the use of our blood tests to screen for cancer early. It also reinforces our deep commitment to providing patients with a simple blood test that is accurate and easier than the current standard of care, to catch lung cancer at the earliest stages where there can be better patient outcomes.”
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