- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01141218
Internet-Based Clinical Information and Blood Sample Collection From Patients With Non-Small Cell Lung Cancer Who Never Smoked Cigarettes
Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Never-smokers with lung cancer
|
collection and review, dna and lab biomarker analysis, gene mapping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
one year following collection of final patient data and biospecimen
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William Pao, MD, PhD, Vanderbilt-Ingram Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC THO 0938
- P30CA068485 (U.S. NIH Grant/Contract)
- VU-VICC-THO-0938
- IRB# 090568
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingCaregiver | Stage III Lung Cancer AJCC v7 | Stage I Lung Cancer AJCC v7 | Stage II Lung Cancer AJCC v7 | Stage IB Lung Cancer AJCC v7 | Stage IA Lung Cancer AJCC v7 | Stage IIA Lung Cancer AJCC v7 | Stage IIB Lung Cancer AJCC v7 | Stage IIIA Lung Cancer AJCC v7 | Stage IIIB Lung Cancer AJCC v7United States
-
Dana-Farber Cancer InstituteMedWaves, IncNot yet recruitingLung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung CancerUnited States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
University of California, San FranciscoMerck Sharp & Dohme LLCWithdrawnLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Head and Neck Carcinoma | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung... and other conditionsUnited States
Clinical Trials on internet-based protocol and physician referral
-
Universitat Jaume IMinisterio de Economía y Competitividad, SpainUnknown
-
Universitat Jaume IMinisterio de Economía y Competitividad, SpainCompletedDepression | Anxiety | Emotional DisordersSpain
-
Universitat Jaume INot yet recruiting
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Asociación Civil Impacta Salud...Completed
-
Milton S. Hershey Medical CenterThe University of Texas Health Science Center, Houston; National Institute... and other collaboratorsCompletedOverweight | ObeseUnited States
-
Chinese University of Hong KongCompletedCOMBO Condition | STIGMA Condition | INTERACT Condition | CONTROL ConditionHong Kong
-
Göteborg UniversitySödra Älvsborg Hospital; Habilitation Services in Skaraborg, SkövdeCompletedADHD | Autism Spectrum DisordersSweden
-
The Miriam HospitalUniversity of Pittsburgh; Brown UniversityCompleted
-
University of CalgaryUniversity of AlbertaUnknownHyperglycemia | Cardiovascular Diseases | Hypertension | HyperlipidemiaCanada
-
Vardalinstitutet The Swedish Institute for Health...CompletedAutism Spectrum Disorder | Attention Deficit Hyperactivity Disorder | Tourette's Disorder