Recruiting NCT07062172
Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Dose CT Scan.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Driver Mutation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Low Dose CT Scan
Completed once after screening and eligibility is confirmed.
Primary outcome measures
- Number of lung cancers found [Time frame: 2 years]
Secondary outcome measures (6)
- Number of follow-up CT scans [Time frame: 2 years]
- Number of lung abnormalities detected [Time frame: 2 years]
- Number and type of biopsies performed [Time frame: 2 years]
- Number and type of resections performed [Time frame: 2 years]
- Number of Adverse Events related to study procedures and follow-up interventions [Time frame: 2 years]
- Stage of Lung Cancers Found [Time frame: 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center University of California, Irvine — Orange
Identifiers
NCT: NCT07062172 · 6367 · UCI 24-118