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 June 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00568490
First received: December 4, 2007
Last updated: June 19, 2014
Last verified: June 2014

December 4, 2007
June 19, 2014
September 1998
April 2016   (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 ] [ Designated as safety issue: No ]
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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 2017
April 2016   (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.

Both
18 Years and older
No
Contact: Cato Chan 650-724-4606 catochan@stanford.edu
United States
 
NCT00568490
ENT0016, 15310; CA67166, 73995, SU-11052007-801
Not Provided
Stanford University
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Quynh-Thu Le Stanford University
Stanford University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP