Nodule Solitary PulmonaryNCT03774758
Biomarkers for Risk Stratification in Lung Cancer
An observational study of Nodule Solitary Pulmonary and Non-small Cell Lung Cancer, run by University of California, San Francisco at 3 sites in United States.
Trial summary
This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Nodule Solitary Pulmonary, Non-small Cell Lung Cancer
- What is being tested?
- Guardant Health ct-DNA LUNAR assay
- How many people
- 1,440 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Dec 2017to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, UCSF Medical Center, and the San Francisco General Hospital.
Who may be able to join
- Age ≥ 40 years
- Ability to understand and provide written informed consent
- Willingness to comply with study protocols and provide blood samples.
- Willingness to complete 3-year clinical follow up
Who cannot join
- Active non-cutaneous malignancy within the past 5 years as per medical record or patient report.
- Exclusion criteria for possible follow-up visit blood draw:
- Anemia - measured by hematocrit level of less than 30%, measured after the first blood draw.
- Malnourishment - determined by BMI less than 19. If subject has BMI greater or equal to 19, but has a history of malnourishment, study staff will measure albumin level of subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg per deciliter, or subject will be excluded.
- Severe Chronic Obstructive Pulmonary Disease (COPD) - defined by Gold Stage IV.
- Unstable heart conditions - defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active congestive heart failure, ischemic cardiomyopathy, or history of complications because of previous blood donation.
- Liver cirrhosis.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
Mehrdad Arjomandi, MD, 877-827-3222, cancertrials@ucsf.edu
Mehrdad Arjomandi, M.D.
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Mehrdad Arjomandi, M.D., 877-827-3222, cancertrials@ucsf.edu
Mehrdad Arjomandi, M.D.
- Recruiting
University of California, San Francisco
San Francisco, California, 94122
Mehrdad Arjomandi, MD, 877-827-3222, cancertrials@ucsf.edu
Mehrdad Arjomandi, M.D.
About this study
Official title: Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.
Read the detailed description
Study objectives and statistical approaches to achieve those objectives are determined at the level of the populations described below:
Population 1: Sensitivity and Specificity Thresholding.
In this phase, the technical feasibility of the intended use case will be assessed in the intended use population relative to known cancer status as established by standard clinical methods. ctDNA samples from enrolled patients will be assessed in each of the following cohorts:
Cohort 1A: High-risk patients negative for lung cancer by CT screening and clinical follow-up.
Cohort 1B: Patients with lung nodules ≥6 mm by CT but negative for lung cancer by extended (3 years) CT screening follow-up.
Cohort 1C: Patients with lung cancer (histologically proven or by consensus tumor board opinion of ≥90% probability of cancer) prior to definitive therapy.
Population 2: Clinical Intended Use Performance. In this phase, the clinical performance of the ctDNA assay will be evaluated in patients with high clinical suspicion for lung cancer. ctDNA will be compared to the clinical diagnosis made according to the standard of care (e.g. biopsy, CT surveillance, etc.). ctDNA samples from enrolled patients will be assessed in each of the following cohorts:
Cohort 2A: High-risk patients newly positive (Lung imaging Reporting And Data System (Lung-RADS) >=3) by CT screening.
Cohort 2B: Patients with >= 6 mm lung nodules suspicious for lung cancer by treating physician judgment.
Cohort 2C: Patients with a personal history of lung cancer after completion of curative intent treatment but without evidence of recurrence.
Specific Aim 1: To estimate the ctDNA assay sensitivity and specificity requirements in the specific clinical use populations using patients with known non-small cell lung cancer status.
Specific Aim 2: To prospectively estimate the ctDNA assay clinical performance in the clinical application of interest.
ENDPOINTS
Primary Endpoints
Specific Aim 1: Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up**.
*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.
**Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and consensus clinical opinion.
Specific Aim 2: Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).
Secondary Endpoints
- Correlation of the ctDNA assay performance with Lung-RADS radiographic criteria
- Correlation of Lung-RADS with disease truth defined by clinical follow up as the definite gold standard
Exploratory Endpoints
- Correlation of plasma and tissue genotyping results
- Correlation of the ctDNA assay with orthogonal reference technologies (e.g. ddPCR)
- Correlation of the ctDNA assay performance with histologic sub-type and clinical course (e.g. aggressive vs. indolent disease)
- Correlation of the ctDNA assay performance with clinical lung cancer risk factors
- Correlation of the ctDNA assay results pre-and post-resection
- Correlation of follow-up the ctDNA assay results and kinetics vs. clinical recurrence post-resection or radiotherapy
- Estimation of theoretical biopsy avoidance rate in clinical use population.
- Being tested
- Guardant Health ct-DNA LUNAR assay
- Keywords
- Lung cancer screening, Biomarkers of lung cancer, Circulating tumor DNA, Low dose computed tomography of lung, Pulmonary nodule
- Medical subject headings
- Solitary Pulmonary Nodule, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardant Health ct-DNA LUNAR assayDiagnostic test
Also called Liquid biopsy Using NGS to Assay high-Risk patients
Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A: Benign nodule on screening CT | High-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2).
1. ≥30 pack-year history of cigarette smoking
2. ≥55 years of age
3. Current smoker or quit within the past 15 years Receives: Diagnostic Test: Guardant Health ct-DNA LUNAR assay | |
| Cohort 1B: Incidental benign nodule | Patients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion.
1- Age ≥40 years. Receives: Diagnostic Test: Guardant Health ct-DNA LUNAR assay | |
| Cohort IC: Presumed lung cancer | Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy.
1- Age ≥40 years. Receives: Diagnostic Test: Guardant Health ct-DNA LUNAR assay | |
| Cohort 2A: Suspicious nodule | High-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening.
1. ≥30 pack-year history of cigarette smoking
2. ≥55 years of age
3. Current smoker or quit within the past 15 years Receives: Diagnostic Test: Guardant Health ct-DNA LUNAR assay | |
| Cohort 2B: Suspicious incidental nodule | Patients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment.
1- Age ≥40 years. Receives: Diagnostic Test: Guardant Health ct-DNA LUNAR assay | |
| Cohort 2C: Post-treatment lung cancer | Patients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +/- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease.
1- Age ≥40 years. Receives: Diagnostic Test: Guardant Health ct-DNA LUNAR assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of ct-DNA LUNAR Assay
Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up**.
*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.
Measured: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
Prospective negative predictive value of ct-DNA LUNAR assay
Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).
Measured: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start17 Dec 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nodule Solitary PulmonaryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,440 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Northern California Institute of Research and Education, Guardant Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Mehrdad Arjomandi, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774758
- Sponsor's protocol ID
- 17-22915
- Other IDs
- 176517
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2018
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT03774758
- Acronym / sponsor ID
- 17-22915
- Keywords
- Lung cancer screening, Biomarkers of lung cancer, Circulating tumor DNA, Low dose computed tomography of lung, Pulmonary nodule
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Northern California Institute of Research and Education, Guardant Health, Inc.
- Study start
- 17 Dec 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.
Detailed description
Study objectives and statistical approaches to achieve those objectives are determined at the level of the populations described below:
Population 1: Sensitivity and Specificity Thresholding.
In this phase, the technical feasibility of the intended use case will be assessed in the intended use population relative to known cancer status as established by standard clinical methods. ctDNA samples from enrolled patients will be assessed in each of the following cohorts:
Cohort 1A: High-risk patients negative for lung cancer by CT screening and clinical follow-up.
Cohort 1B: Patients with lung nodules ≥6 mm by CT but negative for lung cancer by extended (3 years) CT screening follow-up.
Cohort 1C: Patients with lung cancer (histologically proven or by consensus tumor board opinion of ≥90% probability of cancer) prior to definitive therapy.
Population 2: Clinical Intended Use Performance. In this phase, the clinical performance of the ctDNA assay will be evaluated in patients with high clinical suspicion for lung cancer. ctDNA will be compared to the clinical diagnosis made according to the standard of care (e.g. biopsy, CT surveillance, etc.). ctDNA samples from enrolled patients will be assessed in each of the following cohorts:
Cohort 2A: High-risk patients newly positive (Lung imaging Reporting And Data System (Lung-RADS) >=3) by CT screening.
Cohort 2B: Patients with >= 6 mm lung nodules suspicious for lung cancer by treating physician judgment.
Cohort 2C: Patients with a personal history of lung cancer after completion of curative intent treatment but without evidence of recurrence.
Specific Aim 1: To estimate the ctDNA assay sensitivity and specificity requirements in the specific clinical use populations using patients with known non-small cell lung cancer status.
Specific Aim 2: To prospectively estimate the ctDNA assay clinical performance in the clinical application of interest.
ENDPOINTS
Primary Endpoints
Specific Aim 1: Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up**.
*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.
**Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and consensus clinical opinion.
Specific Aim 2: Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).
Secondary Endpoints
- Correlation of the ctDNA assay performance with Lung-RADS radiographic criteria
- Correlation of Lung-RADS with disease truth defined by clinical follow up as the definite gold standard
Exploratory Endpoints
- Correlation of plasma and tissue genotyping results
- Correlation of the ctDNA assay with orthogonal reference technologies (e.g. ddPCR)
- Correlation of the ctDNA assay performance with histologic sub-type and clinical course (e.g. aggressive vs. indolent disease)
- Correlation of the ctDNA assay performance with clinical lung cancer risk factors
- Correlation of the ctDNA assay results pre-and post-resection
- Correlation of follow-up the ctDNA assay results and kinetics vs. clinical recurrence post-resection or radiotherapy
- Estimation of theoretical biopsy avoidance rate in clinical use population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A: Benign nodule on screening CT | – | Diagnostic Test: Guardant Health ct-DNA LUNAR assayHigh-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2). 1. ≥30 pack-year history of cigarette smoking 2. ≥55 years of age 3. Current smoker or quit within the past 15 years |
| Cohort 1B: Incidental benign nodule | – | Diagnostic Test: Guardant Health ct-DNA LUNAR assayPatients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion. 1- Age ≥40 years. |
| Cohort IC: Presumed lung cancer | – | Diagnostic Test: Guardant Health ct-DNA LUNAR assayPatients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy. 1- Age ≥40 years. |
| Cohort 2A: Suspicious nodule | – | Diagnostic Test: Guardant Health ct-DNA LUNAR assayHigh-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening. 1. ≥30 pack-year history of cigarette smoking 2. ≥55 years of age 3. Current smoker or quit within the past 15 years |
| Cohort 2B: Suspicious incidental nodule | – | Diagnostic Test: Guardant Health ct-DNA LUNAR assayPatients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment. 1- Age ≥40 years. |
| Cohort 2C: Post-treatment lung cancer | – | Diagnostic Test: Guardant Health ct-DNA LUNAR assayPatients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +/- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease. 1- Age ≥40 years. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, UCSF Medical Center, and the San Francisco General Hospital.
Key inclusion criteria (4 listed)
- Age ≥ 40 years
- Ability to understand and provide written informed consent
- Willingness to comply with study protocols and provide blood samples.
- Willingness to complete 3-year clinical follow up
Key exclusion criteria (7 listed)
- Active non-cutaneous malignancy within the past 5 years as per medical record or patient report.
- Exclusion criteria for possible follow-up visit blood draw:
- Anemia - measured by hematocrit level of less than 30%, measured after the first blood draw.
- Malnourishment - determined by BMI less than 19. If subject has BMI greater or equal to 19, but has a history of malnourishment, study staff will measure albumin level of subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg per deciliter, or subject will be excluded.
- Severe Chronic Obstructive Pulmonary Disease (COPD) - defined by Gold Stage IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guardant Health ct-DNA LUNAR assayAlso: Liquid biopsy Using NGS to Assay high-Risk patientsGuardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease. | Diagnostic test | Cohort 1A: Benign nodule on screening CT, Cohort 1B: Incidental benign nodule, Cohort 2A: Suspicious nodule, Cohort 2B: Suspicious incidental nodule, Cohort 2C: Post-treatment lung cancer, Cohort IC: Presumed lung cancer |
Primary outcome
Sensitivity and specificity of ct-DNA LUNAR Assay
Time frame: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up**. *Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.
Prospective negative predictive value of ct-DNA LUNAR assay
Time frame: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehrdad Arjomandi, M.D. principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nodule Solitary Pulmonary and Non-small Cell Lung Cancer, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehrdad Arjomandi, MD (877-827-3222, cancertrials@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of ct-DNA LUNAR Assay (time frame: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.