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

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00583934
First received: December 21, 2007
Last updated: July 12, 2010
Last verified: July 2010
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?

Resource links provided by NLM:


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

tissue


Enrollment: 19
Study Start Date: September 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Gregory Farwell, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Gregory Farwell, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00583934     History of Changes
Other Study ID Numbers: 200513668-3, 00004557
Study First Received: December 21, 2007
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
esophageal cancer, head and neck cancer, dysplasia

Additional relevant MeSH terms:
Esophageal Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 19, 2014