Active — Not RecruitingNot Applicable

Screening for High Frequency Malignant Disease

United States12,000 participantsStarted 2022-01-13

Plain-language summary

The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.

Who can participate

Age range50 Years – 80 Years

SexALL

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Exclusion criteria

✕. Subject has quit smoking for 15 or more years
✕. Subject has less than 20 pack-year smoking history
✕. Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery
✕. Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer
✕. Preexisting or history of lung cancer
✕. Previously diagnosed high-risk lung lesion
✕. History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
✕. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs

What they're measuring

Performance characteristics of Guardant LUNAR-2 test

Timeframe: 36 months

Trial details

NCT IDNCT05117840

SponsorGuardant Health, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Lung Cancer trials