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

NCT ID: NCT07062172

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1753 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2028-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low Dose CT Scan

Intervention Type: DIAGNOSTIC_TEST

Completed once after screening and eligibility is confirmed.

Interventions

Low Dose CT Scan

Completed once after screening and eligibility is confirmed.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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:

• 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

Cohort B:

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Hari Keshava

HS Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-8839

University of California Irvine Medical

Role: CONTACT

Facility Contacts

Hari Keshava, MD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 24-118

Identifier Type: OTHER

Identifier Source: secondary_id

6367

Identifier Type: -

Identifier Source: org_study_id