NCT03774758 Biomarkers for Risk Stratification in Lung Cancer
| NCT ID | NCT03774758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Nodule Solitary Pulmonary |
| Study Type | OBSERVATIONAL |
| Enrollment | 590 participants |
| Start Date | 2017-12-17 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 590 participants in total. It began in 2017-12-17 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.
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.
Contact & Investigator
Mehrdad Arjomandi, M.D.
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT03774758 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Nodule Solitary Pulmonary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03774758 currently recruiting?
Yes, NCT03774758 is actively recruiting participants. Contact the research team at cancertrials@ucsf.edu for enrollment information.
Where is the NCT03774758 trial being conducted?
This trial is being conducted at San Francisco, United States, San Francisco, United States, San Francisco, United States.
Who is sponsoring the NCT03774758 clinical trial?
NCT03774758 is sponsored by University of California, San Francisco. The principal investigator is Mehrdad Arjomandi, M.D. at University of California, San Francisco. The trial plans to enroll 590 participants.