NCT00583934

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 13, 2010

Status Verified

July 1, 2010

Enrollment Period

2.2 years

First QC Date

December 21, 2007

Last Update Submit

July 12, 2010

Conditions

Keywords

esophageal cancer, head and neck cancer, dysplasia

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

A

Those six months post treatment for head and neck cancer.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Esophageal NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Gregory Farwell, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 2, 2008

Study Start

September 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

July 13, 2010

Record last verified: 2010-07

Locations