Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer
Recruiting · NCT07062172 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Irvine
View the official record on ClinicalTrials.gov →Interventions studied
Low Dose CT Scan
What this trial is 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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Chao Family Comprehensive Cancer Center University of California, Irvine - Orange, California, United States