Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial? - Full Text View

Purpose

The purpose of this study is to evaluate the prevalence of esophageal pathology in asymptomatic patients with a history of head and neck cancer.

Condition

Esophageal Cancer

MedlinePlus related topics:

Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional

Official Title:	Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Early detection of esophageal cancer or dysplasia in patients without symptoms, after treating their primary cancer, may improve their chances of being cured of a secondary disease. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

tissue

Estimated Enrollment:	100
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts

A

Those six months post treatment for head and neck cancer.

Detailed Description:

There are certain factors (i.e. alcohol, tobacco, decreased saliva production from radiation) that predispose patients with a history of head and neck cancer to have esophageal disease. Often, in the initial stages of the disease, patients do not have symptoms. However, the early detection of precancerous lesions or small cancers improves patients' chances of being cured. There is no direct data supporting the practice of screening patients with a history of head and neck cancer after treatment for esophageal disease if they are not experiencing symptoms. However, many argue that screening endoscopy is justified in high risk patients to detect early esophageal cancer or dysplasia at a curable state. We are, therefore, performing this study to determine the value of endoscopic screening of the esophagus after treatment for head and neck cancer in patients without symptoms.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Subject population will be recruited from the clinical practice of the investigators.

Criteria

Inclusion Criteria:

Head and neck cancer patients that are six months post treatment and asymptomatic for esophageal disease.

Exclusion Criteria:

None if meets the inclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583934

Locations


United States, California
	University of California Davis Medical Center	Recruiting
	Sacramento, California, United States, 95817
	Contact: Greogry Farwell, MD 916-734-8169
	Contact: Peter Belafsky, MD, Ph.D. 916-734-6581
	Principal Investigator: Gregory Farwell, MD

Sponsors and Collaborators

University of California, Davis

Investigators


Principal Investigator:	Gregory Farwell, MD	University of California, Davis

More Information

Responsible Party:	University of California, Davis ( Gregory Farwell, MD )
Study ID Numbers:	200513668-3, 00004557
First Received:	December 21, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00583934
Health Authority:	United States: Institutional Review Board