Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
There are no exclusion criteria for 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.
Trial design
Design model
Single group
Treatments tested in this trial
Low Dose CT Scan
Diagnostic testCompleted once after screening and eligibility is confirmed.
Treatment groups
1,753 Participants
are divided into 1 treatment groupGroup A: Low Dose CT Scan of First Degree Relatives of Lung Cancer PatientsExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
2 yearsSecondary outcomes
1
Number of follow-up CT scans
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.
Time frame
2 years2
Number of lung abnormalities detected
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.
Time frame
2 years3
Number and type of biopsies performed
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.
Time frame
2 years4
Number and type of resections performed
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.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov