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Internet-Based Clinical Information and Blood Sample Collection From Patients With Non-Small Cell Lung Cancer Who Never Smoked Cigarettes

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01141218
First Posted: June 10, 2010
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vanderbilt-Ingram Cancer Center
  Purpose

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.


Condition Intervention
Lung Cancer Other: internet-based protocol and physician referral

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Feasibility of an internet-based protocol to collect clinical information and biological specimens [ Time Frame: Six months following collection of final patient data and biospecimen ]
  • Identification of alleles that predispose to lung cancer via genome-wide association studies [ Time Frame: one year following collection of final patient data and biospecimen ]

Enrollment: 88
Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Never-smokers with lung cancer Other: internet-based protocol and physician referral
collection and review, dna and lab biomarker analysis, gene mapping

Detailed Description:

OBJECTIVES:

  • To assess the feasibility of an internet-based protocol to collect clinical information and biological specimens from 2,000 never smokers with non-small cell lung cancer.
  • To perform genome-wide association studies to identify alleles that predispose to lung cancer in patients that never smoked cigarettes.

OUTLINE:

Patients complete an internet-based questionnaire using the REDCap (Research Electronic Data Capture) survey to determine eligibility. The survey consists of a detailed smoking questionnaire and questions to collect information regarding diagnosis, sex, age, ethnicity, treatment history, and any history of previous malignancies. Blood samples are then collected from eligible patients for DNA and other laboratory analyses. Patients' pathology reports are also reviewed.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
never-smokers with lung cancer
Criteria

Inclusion Criteria:

  • 18 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
  • completed survey and inclusion form
  • signed informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141218


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: William Pao, MD, PhD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Responsible Party: Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01141218     History of Changes
Other Study ID Numbers: VICC THO 0938
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0938
IRB# 090568
First Submitted: June 9, 2010
First Posted: June 10, 2010
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Vanderbilt-Ingram Cancer Center:
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms