Chest Computed Tomography (CT) Screening Study With Antib... | NCT01203579

Studies
Chest Computed Tomography (CT) Screening Study With Antibody Testing

NCT01203579

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Jun 21, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to lack of funding

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2012

Last Update Posted Date

Jun 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

EarlyCDT-Lung test and CT scan both for lung cancer detection and potential economic outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Midthun, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided