NCT01203579

Brief Summary

The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in lung cancer detection and potential health economic outcomes.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

Same day

First QC Date

September 15, 2010

Last Update Submit

June 20, 2012

Conditions

Lung Cancer

Keywords

CDT-Lung,CT scan,lung cancer detection

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Current or Former Smokers with \>20 pack year history and or family history of lung cancer. Ages 50-75 years old

* Persons 50-75 * Asymptomatic for lung cancer * Current or former (stopped smoking less than 10 years ago) cigarette smokers * History of cigarette smoking of at least 20 pack years * History of cigarette smoking with a family history of lung cancer which gives an individual a personal risk similar to a smoking history of 20 pk/years (i.e. 1% at 5 years). * Mentally competent individuals to sign an informed consent. * Healthy enough to undergo pulmonary resection or stereotactic body radiotherapy. * A fully informed signed consent form must have been obtained.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • David Midthun, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

US(1)