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

Lung Cancer Clinical Trial

Official title:

Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01141218
• Other study ID #: VICC THO 0938
• Secondary ID: P30CA068485VU-VI
• Status: Terminated
• Phase: N/A
• First received: June 9, 2010
• Last updated: April 21, 2017
• Start date: July 2009
• Est. completion date: September 2012

Study information

• Verified date: April 2017
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• internet-based protocol and physician referral
collection and review, dna and lab biomarker analysis, gene mapping

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of an internet-based protocol to collect clinical information and biological specimens		Six months following collection of final patient data and biospecimen
Primary	Identification of alleles that predispose to lung cancer via genome-wide association studies		one year following collection of final patient data and biospecimen

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial