Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT07062172

Conditions

Lung Cancer

Driver Mutation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low Dose CT Scan

Study Details

Brief summary:

This is a single-armed screening research study which screens immediate family member of lung cancer patients with a driver mutation to see if lung cancer can be inherited and whether researchers can find lung cancer early. Immediate family members of lung cancer patients will be 40-80 years old and screened using a low dose CT scan.

Conditions

Lung Cancer

Driver Mutation

Study ID

NCT07062172

Start date

May 8, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Cohort A:

Inclusion Criteria:

  • Current diagnosis of lung cancer with a driver mutation.
  • Known driver mutation (e.g. via NGS, PCR, IHC, FISH, RT-PCR etc.)
  • Able and willing to give informed consent.
  • Able and willing to complete the screening questionnaire.

Cohort A:

Exclusion Criteria:

  • There are no exclusion criteria for Cohort A.

Cohort B:

Inclusion Criteria:

  • Age 40 - 80.
  • Must have a first degree relative (mother, father, sibling, biological child) eligible for Cohort A. Note: Multiple first degree relatives of a Cohort A eligible participant may be approached for participation into the trial.
  • Smoked < 20 pack years; a. Pack years = numbers of packs per day × number of years smoked; b. One pack year is the equivalent of smoking an average of 20 cigarettes (1 pack) per day for a year.
  • Be able to undergo a low dose chest CT scan.
  • If an upper respiratory infection (pneumonia, COVID19, flu, etc.) occurred in the last 3 months, this infection must have resolved by time of enrollment.
  • Able and willing to provide informed consent.
  • Able and willing to comply with the protocol requirements

Cohort B:

Exclusion Criteria:

  • Previous history of lung cancers.
  • Symptoms suggestive of presence of current lung cancer, including (but not limited to): unexplained weight loss of over 15 pounds within the last 12 months or unexplained hemoptysis.
  • Pregnant at time of enrollment.
  • History of any type of cancer within 5 years, with the exception of in situ carcinomas and non-melanoma skin cancers (if excised).
  • Current smoker.
  • Smoked ≥ 20 pack years.
  • Had a chest CT scan within 1 year of study entry.

Study Design

Enrollment

1753 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Low Dose CT Scan of First Degree Relatives of Lung Cancer Patients

First degree relatives of patients with lung cancer with a known driver mutation will receive a low dose CT scan of the chest to screen for lung abnormality.

Interventions

Low Dose CT Scan

Completed once after screening and eligibility is confirmed.

Primary outcome measure

  • Number of lung cancers found [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Hari Keshava, MD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Jul 14, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2025-07-14.