Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers

This study is currently recruiting participants.

Verified September 2010 by Stanford University

First Received on December 4, 2007. Last Updated on September 8, 2010 History of Changes

Sponsor:	Stanford University
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00568490

Purpose

To correlate tumor oxygenation as measured by the Eppendorf electrode with the serum level of secreted proteins known to be induced by tumor hypoxia.

Condition	Intervention
Head and Neck Cancer Lung Cancer Lip Cancer Lip Neoplasms Head and Neck Cancers	Procedure: Eppendorf electrode measurements Procedure: Tumor biopsy Procedure: Phlebotomy

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Stanford University:

Biospecimen Retention: Samples Without DNA

blood, tumor tissue

Estimated Enrollment:	600
Study Start Date:	September 1998
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Detailed Description:

The endpoints of the study are

To validate the prognostic significance of OPN in H&N and lung cancer patients and to monitor its level during active therapy and follow up for cancer surveillance.
To identify a gene and protein signature for hypoxia in H&N and lung cancer patients.

Eligibility

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

Study Population

Newly diagnosed patients with head and neck cancer

Criteria

Inclusion Criteria:Newly diagnosed patients with head and neck cancer who has tumor accessible to tumor oxygenation measurement with a microelectrode.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568490

Contacts

Contact: Brindhath Bavan

(650) 725-4777

brindhas@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Brindhath Bavan 650-725-4777 brindhas@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Principal Investigator: Quynh-Thu Le
Sub-Investigator: Amato Giaccia
Sub-Investigator: Richard L Goode
Sub-Investigator: Harlan Pinto
Sub-Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D.

Sponsors and Collaborators

Stanford University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Quynh-Thu Le

Stanford University

More Information

No publications provided

Responsible Party:	Quynh-Thu Le, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00568490 History of Changes
Obsolete Identifiers:	NCT00185822
Other Study ID Numbers:	SU-11052007-801, 15310; CA67166, 73995, ENT0016
Study First Received:	December 4, 2007
Last Updated:	September 8, 2010
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Head and Neck Neoplasms
Lip Neoplasms
Lung Neoplasms
Anoxia
Neoplasms by Site
Mouth Neoplasms
Lip Diseases

Mouth Diseases
Stomatognathic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012