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

June 27, 2025 updated by: Stanford University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • 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.
        • Contact:
        • Contact:
          • Cancer Clinical Trials Office
          • Phone Number: (650) 498-7061

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed patients with head and neck cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of Secreted Markers for Tumor Hypoxia through tissue collection
Time Frame: before therapy, weekly during therapy
before therapy, weekly during therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Quynh-Thu Le, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 1998

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimated)

December 6, 2007

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-10564
  • 73995 (Other Identifier: Stanford University Alternate IRB Approval Number)
  • SU-11052007-801 (Other Identifier: Stanford University)
  • R01DE029672-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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