NCT01141218

Brief Summary

RATIONALE: Gathering health information about patients with non-small cell lung cancer who never smoked cigarettes may help doctors learn more about the disease. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer. PURPOSE: This research study is studying internet-based clinical information and blood sample collection from patients with non-small cell lung cancer who never smoked cigarettes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3.1 years

First QC Date

June 9, 2010

Last Update Submit

April 21, 2017

Conditions

Keywords

non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Feasibility of an internet-based protocol to collect clinical information and biological specimens

    Six months following collection of final patient data and biospecimen

  • Identification of alleles that predispose to lung cancer via genome-wide association studies

    one year following collection of final patient data and biospecimen

Study Arms (1)

Never-smokers with lung cancer

Other: internet-based protocol and physician referral

Interventions

collection and review, dna and lab biomarker analysis, gene mapping

Never-smokers with lung cancer

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

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, except for superficial skin cancers)
  • living outside the United States
  • patients who cannot read English (as materials 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 (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • William Pao, MD, PhD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 10, 2010

Study Start

July 1, 2009

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations