RightFit
RecruitingPhase not listed

Biomarkers for Risk Stratification in Lung Cancer

Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people age 40 and older who get lung cancer screening at three San Francisco hospitals: the VA, UCSF, and San Francisco General. It checks how well a blood test detects ctDNA, which is DNA from cancer cells.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 40 or older.
  • Be able to understand the study and give written consent.
  • Be willing to follow study rules and give blood samples.
  • Be willing to have follow-up care for 3 years.

Who can't join

  • Have had active cancer other than skin cancer in the past 5 years.
  • For a possible follow-up blood draw: anemia, or too few red blood cells, with a hematocrit below 30% after the first blood draw.
  • For a possible follow-up blood draw: poor nutrition, with a body mass index (BMI) below 19. If BMI is 19 or higher but you have a history of poor nutrition, your blood albumin (a protein) must be above 2.5 mg per deciliter.
  • For a possible follow-up blood draw: very severe COPD, a long-term lung disease, called GOLD stage IV.
  • For a possible follow-up blood draw: angina (heart-related chest pain), a heart attack in the past 2 years, active heart failure, heart muscle damage from poor blood flow, or past problems from donating blood.
  • For a possible follow-up blood draw: cirrhosis, or scarring of the liver.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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.

Study sites (3)

CA