Lung CancerNCT01141218
Internet-Based Clinical Information and Blood Sample Collection From Patients With Non-Small Cell Lung Cancer Who Never Smoked Cigarettes
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- internet-based protocol and physician referral
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: never-smokers with lung cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- internet-based protocol and physician referral
- Keywords
- non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based protocol and physician referralOther
collection and review, dna and lab biomarker analysis, gene mapping
| Study group | Role | What they receive |
|---|---|---|
| Never-smokers with lung cancer | Not described Receives: Other: internet-based protocol and physician referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of an internet-based protocol to collect clinical information and biological specimens
Measured: Six months following collection of final patient data and biospecimen
Identification of alleles that predispose to lung cancer via genome-wide association studies
Measured: one year following collection of final patient data and biospecimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2012
- Study completionSep 2012
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William Pao, MD, PhD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141218
- Sponsor's protocol ID
- VICC THO 0938
- Other IDs
- P30CA068485, VU-VICC-THO-0938, IRB# 090568
- Status last verified
- Apr 2017
- First submitted
- 9 Jun 2010
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes
- ClinicalTrials.gov ID
- NCT01141218
- Acronym / sponsor ID
- VICC THO 0938
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Never-smokers with lung cancer | – | Other: internet-based protocol and physician referral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- never-smokers with lung cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-based protocol and physician referralcollection and review, dna and lab biomarker analysis, gene mapping | Other | Never-smokers with lung cancer |
Primary outcome
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
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
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Pao, MD, PhD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.