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

University of California Irvine (UCI)

Status: Enrolling

Conditions: Driver Mutation; Lung Cancer

Treatments: Diagnostic Test: Low Dose CT Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT07062172

UCI 24-118 (Other Identifier)

6367

Details and patient eligibility

About

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.

Enrollment: 1,753 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,753 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Low Dose CT Scan