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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:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Pao, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01141218
First received: June 9, 2010
Last updated: April 2, 2013
Last verified: February 2013
History of Changes
  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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: William Pao, MD, Associate Professor of Medicine, Cancer Biology, & Pathology/Microbiology/Immunology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01141218     History of Changes
Other Study ID Numbers: VICC THO 0938, P30CA068485, VU-VICC-THO-0938, IRB# 090568
Study First Received: June 9, 2010
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 21, 2013