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Biomarkers for Risk Stratification in Lung Cancer

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ClinicalTrials.gov Identifier: NCT03774758
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : June 17, 2020
Sponsor:
Collaborators:
Northern California Institute of Research and Education
Guardant Health, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.

Condition or disease Intervention/treatment
Nodule Solitary Pulmonary Non-small Cell Lung Cancer Diagnostic Test: Guardant Health ct-DNA LUNAR assay

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 590 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
Actual Study Start Date : December 17, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Diagnostic Test: Guardant Health ct-DNA LUNAR assay
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.
Other Name: Liquid biopsy Using NGS to Assay high-Risk patients

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay
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.
Other Name: Liquid biopsy Using NGS to Assay high-Risk patients

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay
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.
Other Name: Liquid biopsy Using NGS to Assay high-Risk patients

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
Diagnostic Test: Guardant Health ct-DNA LUNAR assay
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.
Other Name: Liquid biopsy Using NGS to Assay high-Risk patients

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay
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.
Other Name: Liquid biopsy Using NGS to Assay high-Risk patients

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay
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.
Other Name: Liquid biopsy Using NGS to Assay high-Risk patients




Primary Outcome Measures :
  1. 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.


  2. 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).


Biospecimen Retention:   Samples With DNA
The goal of this study is to evaluate the ability of cell-free circulating tumor DNA (ctDNA) using Guardant Health's LUNAR technology to detect early stage in lung cancer as compared to healthy volunteers and those patients at high risk for lung cancer, but without a lung cancer diagnosis. ctDNA arises when DNA fragments are released into the bloodstream after cell death and is distinguished from non-cancerous cell-free DNA (cfDNA) by the presence of somatic alterations, e.g. mutations, gene amplifications, and fusions. In advanced stage non-small cell lung cancer (NSCLC), evaluation of ctDNA in plasma can be used detect the presence of resistance mutations and ultimately guide treatment while obviating the need for tissue biopsy.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774758


Contacts
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Contact: Mehrdad Arjomandi, MD 877-827-3222 cancertrials@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital and Trauma Center Recruiting
San Francisco, California, United States, 94110
Contact: Mehrdad Arjomandi, MD    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Mehrdad Arjomandi, M.D.         
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Mehrdad Arjomandi, M.D.    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Mehrdad Arjomandi, M.D.         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94122
Contact: Mehrdad Arjomandi, MD    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Mehrdad Arjomandi, M.D.         
Sponsors and Collaborators
University of California, San Francisco
Northern California Institute of Research and Education
Guardant Health, Inc.
Investigators
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Principal Investigator: Mehrdad Arjomandi, M.D. University of California, San Francisco
Additional Information:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03774758    
Other Study ID Numbers: 17-22915
176517 ( Other Identifier: University of California, San Francisco )
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Lung cancer screening
Biomarkers of lung cancer
Circulating tumor DNA
Low dose computed tomography of lung
Pulmonary nodule
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases