Screening for High Frequency Malignant Disease
Blood test to screen for lung cancer in high-risk individuals
Plain English Summary
Screening for High Frequency Malignant Disease is a Not Applicable clinical trial sponsored by Guardant Health, Inc. studying Lung Cancer. This study tests a new blood test called GuardantLUNAR-2 to see how well it can find lung cancer. It is for individuals aged 50-80 who have a high risk of developing lung cancer. Participation involves providing a blood sample during a routine lung cancer screening CT scan. The alternative is standard lung cancer screening with low-dose CT scans alone. The trial aims to enroll 12000 participants.
Official 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
Here is what you need to know about eligibility for this trial. You can join if you are between 50 and 80 years old. You must have a history of smoking at least 20 pack-years and either currently smoke or quit within the last 15 years. You cannot join if you quit smoking more than 15 years ago, have a life-limiting illness, or have a history of lung cancer or suspicious lung lesions. You also cannot join if you are currently being treated for pneumonia, have had major trauma recently, or are taking certain cancer medications. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how accurately the GuardantLUNAR-2 blood test can identify lung cancer in people who are at high risk, meaning it will show how reliable this new screening tool is. The specific primary outcome measures are: Performance characteristics of Guardant LUNAR-2 test (36 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve early detection of lung cancer through a less invasive blood test, potentially filling a gap in current screening methods. This research targets Lung Cancer, where improved treatment options are needed.
Investor Insight
This trial signals a significant investment in liquid biopsy technology for cancer screening, a rapidly growing market with potential for early disease detection and improved patient outcomes. The large enrollment target of 12000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the high-risk criteria for lung cancer screening and if this study is a good fit for you. Participation involves a blood draw at the same time as your scheduled low-dose CT scan, with follow-up over a year. Be prepared to discuss your smoking history and any past or current health conditions with the study team. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 12,000 participants
Interventions
- DEVICE: Low-dose CT scan — Standard of care screening for individuals at high-risk of lung cancer
Primary Outcomes
- Performance characteristics of Guardant LUNAR-2 test (36 months)
Secondary Outcomes
- Screen detected cancer rate (36 months)
Full Eligibility Criteria
Inclusion Criteria: * Subjects aged 50-80 years at time of consent * Increased risk of lung cancer defined by: at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years * Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening * Willing to consent to the investigational blood draw during index LDCT screening visit and before any invasive procedures or treatment for lung cancer diagnosis * Willing to consent to a 1-year and additional follow-up per protocol Exclusion Criteria: 1. Subject has quit smoking for 15 or more years 2. Subject has less than 20 pack-year smoking history 3. Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery 4. Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer 5. Preexisting or history of lung cancer 6. Previously diagnosed high-risk lung lesion 7. 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) 8. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs 9. Currently receiving treatment for pneumonia 10. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent 11. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study 12. Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening
Trial Locations
- University of Alabama Birmingham Lung Health Center, Birmingham, Alabama, United States
- Highlands Oncology Group PA, Fayetteville, Arkansas, United States
- Pacific Cancer Medical Center, Anaheim, California, United States
- Providence St. Joseph Hospital Eureka Cancer Program, Eureka, California, United States
- SoCal Clinical Research, Fountain Valley, California, United States
- Advanced Investigative Medicine, Hawthorne, California, United States
- Cedars-Sinai Medical Center, Los Angeles, California, United States
- California Medical Research Associates Inc., Northridge, California, United States
- Providence Medical Foundation, Santa Rosa, California, United States
- Starling Physicians, New Britain, Connecticut, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05117840?
NCT05117840 is a Not Applicable OBSERVATIONAL study titled "Screening for High Frequency Malignant Disease." It is currently active, not recruiting and is sponsored by Guardant Health, Inc.. The trial targets enrollment of 12000 participants.
What conditions does NCT05117840 study?
This trial investigates treatments for Lung Cancer. The primary condition under study is Lung Cancer.
What treatments are being tested in NCT05117840?
The interventions being studied include: Low-dose CT scan (DEVICE). Standard of care screening for individuals at high-risk of lung cancer
What does Not Applicable mean for NCT05117840?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05117840?
This trial is currently "Active, Not Recruiting." It started on 2022-01-13. The estimated completion date is 2026-07-30.
Who is sponsoring NCT05117840?
NCT05117840 is sponsored by Guardant Health, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05117840?
The trial aims to enroll 12000 participants. The trial status is active, not recruiting.
How is NCT05117840 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05117840?
The primary outcome measures are: Performance characteristics of Guardant LUNAR-2 test (36 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05117840 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Fayetteville, Arkansas; Anaheim, California; Eureka, California and 16 more sites (United States).
Where can I find official information about NCT05117840?
The official record for NCT05117840 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05117840. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05117840 testing in simple terms?
This study tests a new blood test called GuardantLUNAR-2 to see how well it can find lung cancer. It is for individuals aged 50-80 who have a high risk of developing lung cancer.
Why is this trial significant?
This trial matters because it aims to improve early detection of lung cancer through a less invasive blood test, potentially filling a gap in current screening methods.
What are the potential risks of participating in NCT05117840?
The main risk is that the blood test may not be accurate, leading to false positives (saying you have cancer when you don't) or false negatives (missing cancer that is present). Potential side effects are related to the blood draw, such as bruising or minor discomfort at the needle site. There's also a risk of anxiety or distress if the test results are unclear or indicate a potential issue. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05117840?
Ask your doctor if you meet the high-risk criteria for lung cancer screening and if this study is a good fit for you. Participation involves a blood draw at the same time as your scheduled low-dose CT scan, with follow-up over a year. Be prepared to discuss your smoking history and any past or current health conditions with the study team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05117840 signal from an investment perspective?
This trial signals a significant investment in liquid biopsy technology for cancer screening, a rapidly growing market with potential for early disease detection and improved patient outcomes. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing a blood sample during a routine lung cancer screening CT scan. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.