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RecruitingInterventional

Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer

NCT ID: NCT07062172Sponsor: University of California, IrvineLast updated: 2025-07-14

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.

Arms & interventions

  • Diagnostic TestLow Dose CT Scan

    Completed once after screening and eligibility is confirmed.

Outcome measures

Primary

  • Number of lung cancers found

    Determine the number of lung cancers found in low dose CT scans of first degree relatives of lung cancer patients with known driver mutations.

    Time frame: 2 years

Secondary

  • Number of follow-up CT scans

    Time frame: 2 years

  • Number of lung abnormalities detected

    Time frame: 2 years

  • Number and type of biopsies performed

    Time frame: 2 years

  • Number and type of resections performed

    Time frame: 2 years

  • Number of Adverse Events related to study procedures and follow-up interventions

    Time frame: 2 years

  • Stage of Lung Cancers Found

    Time frame: 2 years

Eligibility criteria

Sex: AllAge: 18 Years to 80 YearsHealthy volunteers: No
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 locations (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868

Recruiting
Hari Keshava, MD · Contact
Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer | Cancerify