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

This study is currently recruiting participants.
Verified July 2016 by Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568490
First Posted: December 6, 2007
Last Update Posted: July 12, 2016
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
December 4, 2007
December 6, 2007
July 12, 2016
September 1998
April 2022   (Final data collection date for primary outcome measure)
Identification of Secreted Markers for Tumor Hypoxia through tissue collection [ Time Frame: before therapy, weekly during therapy ]
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Complete list of historical versions of study NCT00568490 on ClinicalTrials.gov Archive Site
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Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
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.

The endpoints of the study are

  1. 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.
  2. To identify a gene and protein signature for hypoxia in H&N and lung cancer patients.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
blood, tumor tissue
Non-Probability Sample
Newly diagnosed patients with head and neck cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Lip Cancer
  • Lip Neoplasms
  • Head and Neck Cancers
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
April 2022
April 2022   (Final data collection date for primary outcome measure)
Inclusion Criteria:Newly diagnosed patients with head and neck cancer who has tumor accessible to tumor oxygenation measurement with a microelectrode.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT00568490
ENT0016
15310; CA67166
73995 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-11052007-801 ( Other Identifier: Stanford University )
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Stanford University
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Quynh-Thu Le Stanford University
Stanford University
July 2016