Genetic Susceptibility to Lung Cancer in Never Smokers | NCT00597636

Studies
Genetic Susceptibility to Lung Cancer in Never Smokers

NCT00597636

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Active, not recruiting

Last Update Posted

Jun 11, 2026Actual

Enrollment

238Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Questionaire, blood sample
Questionaire, Blood sample

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 17, 2008

First Posted Date

Jan 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 11, 2026Actual

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

238Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		NEVER SMOKERS WITH LUNG CANCER	Behavioral: Questionaire, blood sample
2		NEVER SMOKERS WITHOUT ANY CANCER	Behavioral: Questionaire, Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionaire, blood sample	Behavioral	Provide 30ml blood for laboratory assays Complete Health Questionnaire	1

Measure	Description	Time Frame
To evaluate germline genetic variants and their association with lung cancer in never smokers.		conclusion of study

Measure	Description	Time Frame
To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers.		conclusion of study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

MSKCC clinics

Sampling Method

Non-Probability Sample

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis