Biomarkers for Risk Stratification in Lung Cancer

Description

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.

Conditions

Nodule Solitary Pulmonary, Non-small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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.

Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening

Biomarkers for Risk Stratification in Lung Cancer

Condition
Nodule Solitary Pulmonary
Intervention / Treatment

-

Contacts and Locations

San Francisco

Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, United States, 94110

San Francisco

San Francisco VA Medical Center, San Francisco, California, United States, 94121

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Mehrdad Arjomandi, M.D., PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2024-12-31