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

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ClinicalTrials.gov Identifier: NCT00568490
Recruitment Status : Recruiting
First Posted : December 6, 2007
Last Update Posted : August 2, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

Study Description
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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

  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.
Study Design
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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


Groups and Cohorts
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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
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Primary Outcome Measures :
  1. 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
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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:

  • Histologically confirmed squamous cell carcinoma of the head and neck sites or non-small cell lung cancer, or relatives of patients with histologically confirmed squamous cell carcinoma of the head and neck.
  • Able to sign a Stanford IRB approved consent form

Exclusion criteria:

  • Refuse or unable to sign an IRB approved consent form.
  • Refuse to be contacted in the future for follow up.
Contacts and Locations
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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


Contacts
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Contact: Rachel Freiberg rachelf@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Rachel Freiberg    650-725-0438    rachelf@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
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Principal Investigator: Quynh-Thu Le Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00568490    
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: August 2, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Head and Neck Neoplasms
Lip Neoplasms
Hypoxia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Mouth Neoplasms
Lip Diseases
Mouth Diseases
Stomatognathic Diseases