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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00568490

Recruitment Status : Recruiting

First Posted : December 6, 2007

Last Update Posted : July 12, 2016

See Contacts and Locations

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Stanford University

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Head and Neck Cancer Lung Cancer Lip Cancer Lip Neoplasms Head and Neck Cancers	Procedure: Tumor biopsy Procedure: Phlebotomy

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.

Study Design


Study Type :	Observational
Estimated Enrollment :	600 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
Study Start Date :	September 1998
Estimated Primary Completion Date :	April 2022
Estimated Study Completion Date :	April 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Lung cancer

MedlinePlus related topics: Lung Cancer

Genetic and Rare Diseases Information Center resources: Oral Cancer

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

Identification of Secreted Markers for Tumor Hypoxia through tissue collection [ Time Frame: before therapy, weekly during therapy ]

Biospecimen Retention: Samples Without DNA

blood, tumor tissue

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT00568490 History of Changes
Obsolete Identifiers:	NCT00185822
Other Study ID Numbers:	ENT0016 15310; CA67166 73995 ( Other Identifier: Stanford University Alternate IRB Approval Number ) SU-11052007-801 ( Other Identifier: Stanford University )
First Posted:	December 6, 2007 Key Record Dates
Last Update Posted:	July 12, 2016
Last Verified:	July 2016

Additional relevant MeSH terms:


Lung Neoplasms Head and Neck Neoplasms Hypoxia Lip Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms	Lung Diseases Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Mouth Neoplasms Lip Diseases Mouth Diseases Stomatognathic Diseases

To Top