Clinical trial NCT01141218: Internet-Based Clinical Information and Blood Sample Collection From Patients With Non-Small Cell Lung Cancer Who Never Smoked Cigarettes
Official title: Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: never-smokers with lung cancer

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of an internet-based protocol to collect clinical information and biological specimens
timeFrame: Six months following collection of final patient data and biospecimen
measure: Identification of alleles that predispose to lung cancer via genome-wide association studies
timeFrame: one year following collection of final patient data and biospecimen
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: William Pao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: