Driver Mutation, Lung Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTLow Dose CT Scan
Completed once after screening and eligibility is confirmed.
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lung cancers found | 2 years | Determine the number of lung cancers found in low dose CT scans of first degree relatives of lung cancer patients with known driver mutations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of lung abnormalities detected | 2 years | 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. |
| Number and type of biopsies performed | 2 years | 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. |
| Number of follow-up CT scans | 2 years | 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. |
| Number of Adverse Events related to study procedures and follow-up interventions | 2 years | Determine the number of Adverse Events, per CTCAE 5.0, related to study procedures and follow-up interventions of immediate family members of lung cancer patients with a known driver mutation with a finding of a lung abnormality from a low dose CT scan. |
| Stage of Lung Cancers Found | 2 years | Determine the stages of all lung cancers found in immediate family members of lung cancer patients with a known driver mutation. |
| Number and type of resections performed | 2 years | 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. |
Countries
United States
Contacts
Primary ContactChao Family Comprehensive Cancer Center University of California, Irvine
Backup ContactUniversity of California Irvine Medical
Outcome results
None listed