Identifying biomarkers for lung cancer risk assessment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the performance of circulating tumor DNA (ctDNA) assays in patients undergoing lung cancer screening at various San Francisco medical centers. It will follow two primary populations: one assessing the sensitivity and specificity of ctDNA in patients with known cancer status, and another evaluating its clinical performance in high-risk patients suspected of having lung cancer. Participants will provide blood samples and undergo a three-year clinical follow-up to gather data on the effectiveness of the ctDNA assay compared to standard diagnostic methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zuckerberg San Francisco General Hospital and Trauma Center
  San Francisco, California, United States Recruiting
• San Francisco VA Medical Center
  San Francisco, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Mehrdad Arjomandi, M.D. — University of California, San Francisco
• Study coordinator: Mehrdad Arjomandi, MD
• Email: cancertrials@ucsf.edu
• Phone: 877-827-3222

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies

  This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.

  Recruiting Phase 1/2 Daiichi Sankyo · Taichung · NCT07890714

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery

  This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07837739

• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

  This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.

  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.