Surveillance For New Lung Primaries

November 13, 2019 updated by: University of Wisconsin, Madison

Fluorescence Bronchoscopic Surveillance For New Lung Primaries After Curative Therapy for Squamous Cell Carcinoma of the Aerodigestive Tract"

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Fluorescence bronchosopy with sputum cytology
Patients undergo surgery with Fluorescence bronchosopy and sputum cytology.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Tracey Weigel, MD, University of Wisconsin Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CC01506
  • 2001-431 (Other Identifier: Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe