NCT00597636

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jun 2005Jun 2027

Study Start

First participant enrolled

June 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
19.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

22 years

First QC Date

January 10, 2008

Last Update Submit

June 9, 2026

Conditions

Lung Cancer

Keywords

smokers

Outcome Measures

Primary Outcomes (1)

  • To evaluate germline genetic variants and their association with lung cancer in never smokers.

    conclusion of study

Secondary Outcomes (1)

  • To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers.

    conclusion of study

Study Arms (2)

1

NEVER SMOKERS WITH LUNG CANCER

Behavioral: Questionaire, blood sample

2

NEVER SMOKERS WITHOUT ANY CANCER

Behavioral: Questionaire, Blood sample

Interventions

Questionaire, Blood sampleBEHAVIORAL

Provide 30ml blood for laboratory assays Complete Health Questionnaire

1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSKCC clinics

You may qualify 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.
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Irene Orlow, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 18, 2008

Study Start

June 1, 2005

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations

US(1)