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

Terminated

• Conditions: Lung Cancer
• Interventions: Other: internet-based protocol and physician referral

• Registration Number: NCT01141218
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Never-smokers with lung cancer	internet-based protocol and physician referral	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States