Lung CancerNCT00597636
Genetic Susceptibility to Lung Cancer in Never Smokers
An observational study of Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people who have never smoked and yet have been diagnosed with lung cancer to never smokers who have not developed lung cancer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Questionaire, blood sample
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2027
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- Cases will be eligible for inclusion if:
- They have been diagnosed with a lung cancer or have had previous surgical treatment for their lung cancer and have smoked fewer than 100 cigarettes in their lifetime, are/were not regular cigar or pipe smokers, and
- They have had no prior chemotherapy or radiation treatment within the last year (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected)
- They speak and read English
- They understand and agree to sign informed consent, and
- They agree to give us a blood sample, and
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- They agree to complete the study questionnaire, and
- They agree to have their pathology information reviewed by study personnel.
- Controls will be eligible for inclusion if:
- They have not been diagnosed with any type of cancer, exclusive of nonmelanoma skin cancer and have smoked fewer than 100 cigarettes in their lifetime, are/were not regular cigar or pipe smokers, and
- They speak and read English
- They understand and agree to sign informed consent, and
- They agree to give us a blood sample, and
- They agree to complete the study questionnaire.
Who cannot join
- Subjects who do not meet the inclusion criteria for either the case or control groups will not be eligible for this study.
- All individuals who otherwise meet the eligibility requirements above, but who have had chemotherapy or radiation therapy within 1 year of evaluation will be excluded (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people who have never smoked and yet have been diagnosed with lung cancer to never smokers who have not developed lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final.
- Conditions
- Lung Cancer
- Being tested
- Questionaire, blood sample
- Keywords
- smokers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionaire, blood sampleBehavioural
Provide 30ml blood for laboratory assays Complete Health Questionnaire
Questionaire, Blood sampleBehavioural
Provide 30ml blood for laboratory assays Complete Health Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 1 | NEVER SMOKERS WITH LUNG CANCER Receives: Behavioral: Questionaire, blood sample | |
| 2 | NEVER SMOKERS WITHOUT ANY CANCER Receives: Behavioral: Questionaire, Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate germline genetic variants and their association with lung cancer in never smokers.
Measured: conclusion of study
Secondary outcomes (1)
To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startJun 2005
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Orlow, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597636
- Sponsor's protocol ID
- 05-038
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2008
- Last updated
- 11 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Susceptibility to Lung Cancer in Never Smokers
- ClinicalTrials.gov ID
- NCT00597636
- Acronym / sponsor ID
- 05-038
- Conditions
- Lung Cancer
- Keywords
- smokers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Jan 2008 (estimated)
- 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.
The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people who have never smoked and yet have been diagnosed with lung cancer to never smokers who have not developed lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Questionaire, blood sampleNEVER SMOKERS WITH LUNG CANCER |
| 2 | – | Behavioral: Questionaire, Blood sampleNEVER SMOKERS WITHOUT ANY CANCER |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (14 listed)
- Cases will be eligible for inclusion if:
- They have been diagnosed with a lung cancer or have had previous surgical treatment for their lung cancer and have smoked fewer than 100 cigarettes in their lifetime, are/were not regular cigar or pipe smokers, and
- They have had no prior chemotherapy or radiation treatment within the last year (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected)
- They speak and read English
- They understand and agree to sign informed consent, and
Key exclusion criteria (2 listed)
- Subjects who do not meet the inclusion criteria for either the case or control groups will not be eligible for this study.
- All individuals who otherwise meet the eligibility requirements above, but who have had chemotherapy or radiation therapy within 1 year of evaluation will be excluded (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected).
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 |
|---|---|---|
| Questionaire, blood sampleProvide 30ml blood for laboratory assays Complete Health Questionnaire | Behavioural | 1 |
| Questionaire, Blood sampleProvide 30ml blood for laboratory assays Complete Health Questionnaire | Behavioural | 2 |
Primary outcome
To evaluate germline genetic variants and their association with lung cancer in never smokers.
Time frame: conclusion of study
1 secondary outcome
To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers.
Time frame: conclusion of study
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 11 Jun 2026.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Irene Orlow, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Memorial Sloan Kettering Cancer Center 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 14 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate germline genetic variants and their association with lung cancer in never smokers. (time frame: conclusion of study). 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 11 Jun 2026.