RECRUITING

Biomarkers for Risk Stratification in Lung Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening

Quick Facts

Study Start:2017-12-17
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03774758

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.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 40 years
  2. * Ability to understand and provide written informed consent
  3. * Willingness to comply with study protocols and provide blood samples.
  4. * Willingness to complete 3-year clinical follow up
  1. * Active non-cutaneous malignancy within the past 5 years as per medical record or patient report.
  2. * Exclusion criteria for possible follow-up visit blood draw:
  3. * Anemia - measured by hematocrit level of less than 30%, measured after the first blood draw.
  4. * 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.
  5. * Severe Chronic Obstructive Pulmonary Disease (COPD) - defined by Gold Stage IV.
  6. * 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.
  7. * Liver cirrhosis.

Contacts and Locations

Study Contact

Mehrdad Arjomandi, MD
CONTACT
877-827-3222
cancertrials@ucsf.edu

Principal Investigator

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

Study Locations (Sites)

Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
United States
San Francisco VA Medical Center
San Francisco, California, 94121
United States
University of California, San Francisco
San Francisco, California, 94122
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-12-17
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2017-12-17
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Lung cancer screening
  • Biomarkers of lung cancer
  • Circulating tumor DNA
  • Low dose computed tomography of lung
  • Pulmonary nodule

Additional Relevant MeSH Terms

  • Nodule Solitary Pulmonary
  • Non-small Cell Lung Cancer