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

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2014 by Stanford University

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT00568490

First received: December 4, 2007

Last updated: September 23, 2014

Last verified: September 2014

History of Changes

Purpose

The purpose of this study is to identify and confirm new blood and tissue markers for prognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, has been shown to increase the risk of tumor spread and enhance tumor resistance to the standard treatment of radiation and chemotherapy in head and neck and lung cancers. We have recently identified several proteins or markers in the blood and in tumors (including osteopontin, lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory that may be able to identify tumors with low oxygen levels or more aggressive behaving tumors.

Condition	Intervention
Head and Neck Cancer Lung Cancer Lip Cancer Lip Neoplasms Head and Neck Cancers	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 Lung Cancer

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Identification of Secreted Markers for Tumor Hypoxia through tissue collection [ Time Frame: before therapy, weekly during therapy ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

blood, tumor tissue


Estimated Enrollment:	600
Study Start Date:	September 1998
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Intervention Details:

For patients who undergo tumor biopsy or resection at Stanford, approximately 500 mg of the tumor will be removed from the resection specimen

Blood draw (approximately 20 cc) prior to any anticancer therapy Weekly blood draw (approximately 20cc) only for patients who are undergoing radiation treatment at Stanford University

Other Name: Blood draw

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

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: NCT00568490

Locations


United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Amanda Simmons 650-724-4606 amandals@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:	Stanford University
ClinicalTrials.gov Identifier:	NCT00568490 History of Changes
Obsolete Identifiers:	NCT00185822
Other Study ID Numbers:	ENT0016, 15310; CA67166, 73995, SU-11052007-801
Study First Received:	December 4, 2007
Last Updated:	September 23, 2014
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms Neoplasms by Site

ClinicalTrials.gov processed this record on March 03, 2015

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