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

NCT07062172 | Recruiting

• 2 other identifiers: 6367UCI 24-118
• Study Type: interventional
• Target: 1,753
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (6)

• Number of follow-up CT scans

  2 years

• Number of lung abnormalities detected

  2 years

• Number and type of biopsies performed

  2 years

• Number and type of resections performed

  2 years

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

  2 years

Study Arms (1)

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

EXPERIMENTAL

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.

Diagnostic Test: Low Dose CT Scan

Interventions

Low Dose CT Scan DIAGNOSTIC_TEST

Completed once after screening and eligibility is confirmed.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• Cohort B:
• 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:
• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

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

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Assistant Clinical Professor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)