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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
  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:


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 ]

Biospecimen Retention:   Samples Without DNA
blood, tumor tissue

Estimated Enrollment: 600
Study Start Date: September 1998
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
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
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.
  Eligibility

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, Senior)
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 Submitted: December 4, 2007
First Posted: December 6, 2007
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