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NCT Number: NCT07062172

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Hari Keshava, MD

CONTACT

[email protected]

877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Dose CT Scan

Diagnostic Test

Completed once after screening and eligibility is confirmed.

Primary outcomes

  1. Number of lung cancers found

    Time frame: 2 years

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

Secondary outcomes

  1. Number of follow-up CT scans

    Time frame: 2 years

    Determine the number of follow-up CT scans ordered for first degree relatives of lung cancer patients with a known driver mutation after the initial low dose CT scan with findings of lung abnormalities.

  2. Number of lung abnormalities detected

    Time frame: 2 years

    Determine the number of lung abnormalities found from low dose CT scan of first degree relatives of lung c. after the initial low dose CT scan with findings of lung abnormalities.

  3. Number and type of biopsies performed

    Time frame: 2 years

    Determine the number and type of biopsies performed in follow up to the finding of a lung abnormalities after a low dose CT scan of first degree relatives of lung cancer patients with a known driver mutation.

  4. Number and type of resections performed

    Time frame: 2 years

    Determine the number and type of resections performed in follow up to the finding of a lung abnormality after a low dose CT scan of first degree relatives of lung cancer patients with a known driver mutation.

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

    Time frame: 2 years

    Determine the number of Adverse Events, per CTCAE 5.0, related to study procedures and follow-up interventions of immediate family members of lung cancer patients with a known driver mutation with a finding of a lung abnormality from a low dose CT scan.

  6. Stage of Lung Cancers Found

    Time frame: 2 years

    Determine the stages of all lung cancers found in immediate family members of lung cancer patients with a known driver mutation.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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