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 September 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00568490
First received: December 4, 2007
Last updated: September 23, 2014
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood, tumor tissue


Estimated Enrollment: 600
Study Start Date: September 1998
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Quynh-Thu Le Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00568490     History of Changes
Obsolete Identifiers: NCT00185822
Other Study ID Numbers: ENT0016, 15310; CA67166, 73995, SU-11052007-801
Study First Received: December 4, 2007
Last Updated: September 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lip Neoplasms
Lung Neoplasms
Lip Diseases
Lung Diseases
Mouth Diseases
Mouth Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Stomatognathic Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014