Surveillance For New Lung Primaries | NCT00205439

Studies
Surveillance For New Lung Primaries

NCT00205439

Sponsor

University of Wisconsin, Madison

Status

Terminated

Last Update Posted

Nov 15, 2019Actual

Enrollment

200Estimated

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

ID	Type	Description	Link
2001-431	Other Identifier	Institutional Review Board

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low accrual

Expanded Access Info

Start Date

Dec 2001

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 20, 2005Estimated

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

Nov 13, 2019

Last Update Posted Date

Nov 15, 2019Actual

Description Module

Brief Summary

The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas in patients with a history of squamous cell cancer of the aerodigestive tract who have been treated with a curative intent and remain disease free. Detection of pre-invasive and invasive lesions (moderate to severe dysplasia, CIS) with fluorescence bronchoscopic surveillance may help to define the natural history of these lesions and allow earlier intervention should they progress to invasive lesions.

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluorescence bronchosopy with sputum cytology		Patients undergo surgery with Fluorescence bronchosopy and sputum cytology.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History squamous cell NSCLC who have undergone complete resection or definitive chemotherapy

Exclusion Criteria:

History of an aerodigestive tract carcinoma of non-squamous histology
Patients who have Stage IIIA, IIIB or IV squamous cell lung cancer that have undergone resection or chemotherapy within three years
Patients who have Stage I or II squamous cell lung cancer that have undergone resection or chemotherapy within one year
Patients who have received external beam radiation therapy for treatment of a squamous cell cancer of the lung

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with new lung primaries after curative therapy for squamous cell carcinoma of the aerodigestive tract

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tracey Weigel, MD	University of Wisconsin Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Hospital and Clinics		Madison	Wisconsin	53792	United States

Label	URL
University of Wisconsin Carbone Cancer Center	View source

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