Lung CancerNCT07062172
Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer
A study testing Low Dose CT Scan in people with Lung Cancer and Driver Mutation, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Driver Mutation
- What is being tested?
- Low Dose CT Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,753 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Age 40 - 80.
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- 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:
Who cannot join
- There are no exclusion criteria for Cohort A.
- 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).
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- Current smoker.
- Smoked ≥ 20 pack years.
- Had a chest CT scan within 1 year of study entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
Hari Keshava, MD, 877-827-8839, ucstudy@uci.edu
About this study
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
- Being tested
- Low Dose CT Scan
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose CT ScanDiagnostic test
Completed once after screening and eligibility is confirmed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Low Dose CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Number of Adverse Events related to study procedures and follow-up interventions
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.
Measured: 2 years
Stage of Lung Cancers Found
Determine the stages of all lung cancers found in immediate family members of lung cancer patients with a known driver mutation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start8 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,753 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hari Keshava, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062172
- Sponsor's protocol ID
- 6367
- Other IDs
- UCI 24-118
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer
- ClinicalTrials.gov ID
- NCT07062172
- Acronym / sponsor ID
- 6367
- Conditions
- Lung Cancer, Driver Mutation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,753 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Dose CT Scan of First Degree Relatives of Lung Cancer Patients | Experimental | Diagnostic Test: Low Dose CT ScanFirst 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Age 40 - 80.
Key exclusion criteria (9 listed)
- There are no exclusion criteria for Cohort A.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose CT ScanCompleted once after screening and eligibility is confirmed. | Diagnostic test | Low Dose CT Scan of First Degree Relatives of Lung Cancer Patients |
Primary outcome
Number of lung cancers found
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose CT Scan in people with Lung Cancer and Driver Mutation, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lung cancers found (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.