NCT00745160

Brief Summary

The purpose of this study is to determine if collecting information and blood from a group of people who never smoked but who have lung cancer, is possible across the US. The investigators will collect information on each patient's diagnosis and treatments. If the collection is successful, blood samples will be used to try to identify new genes (which are the basic elements of heredity, passed from parents to their offspring), which may explain and predict why certain patients develop lung cancer without having smoked tobacco.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

5 active sites

Status
completed

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 Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 30, 2011

Status Verified

March 1, 2011

Enrollment Period

2 years

First QC Date

September 2, 2008

Last Update Submit

March 29, 2011

Conditions

Keywords

Questionaires

Outcome Measures

Primary Outcomes (1)

  • To assess the feasibility of an internet-based protocol to collect clinical information and biological specimens from 2,000 never smokers with lung cancer.

    conclusion of the study

Study Arms (1)

1

Never-smokers with lung cancer

Other: blood sample and questionnaire

Interventions

After giving informed consent, all patients will be asked to complete questionnaire and will be asked to provide a blood sample for DNA analysis. The questionnaire will consist of a detailed smoking questionnaire, based on the most recent Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System Survey Questionnaire.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Never-smokers with lung cancer Internet recruitment The study will be advertised through a specifically designed website linked to the MSKCC Lung Cancer webpage. The website will be designed after approval of the study. The website will be accordingly reviewed by the IRB. We plan to advertise this study by word-of mouth at scientific meetings and on patient associations' websites and/or bulletins, with permission. The website will post a description of the study and an invitation to participate. Interested patients will be given an email or mail address and/or phone number 866-854-4652 to contact MSKCC investigators about the study.

You may qualify if:

  • years or older
  • histologically and/or cytologically proven diagnosis of non-small cell lung cancer
  • never smoker, defined as having smoked less than 100 cigarettes over one's life-time
  • signed informed consent

You may not qualify if:

  • previous history of cancer (other than lung cancer)
  • living outside the United States
  • patients who cannot read English (as website and questionnaires will only be written in English)
  • unable to understand the protocol or to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood sample for DNA analysis

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Vincent Miller, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 30, 2011

Record last verified: 2011-03

Locations