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NCT Number: NCT00568490

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.

Recruiting

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Key information

Conditions

Head and Neck Cancer Head and Neck Cancers Head and Neck Neoplasms Lip Cancer Lip Diseases Lip Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatognathic Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Amato Giaccia

SUB_INVESTIGATOR

Cancer Clinical Trials Office

CONTACT

(650) 498-7061

Dr. Billy W. Loo Jr. M.D. Ph.D.

SUB_INVESTIGATOR

Eyiwunmi Laseinde

CONTACT

[email protected]

Harlan Pinto

SUB_INVESTIGATOR

Quynh-Thu Le

PRINCIPAL_INVESTIGATOR

Richard L Goode

SUB_INVESTIGATOR

About this study

The endpoints of the study are

  • 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.
  • To identify a gene and protein signature for hypoxia in H&N and lung cancer patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumor Biopsy

Procedure

For patients who undergo tumor biopsy or resection at Stanford, approximately 500 mg of the tumor will be removed from the resection specimen

Phlebotomy

Procedure

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 names: Blood draw

Primary outcomes

  1. Identification of Secreted Markers for Tumor Hypoxia through tissue collection

    Time frame: before therapy, weekly during therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Eyiwunmi Laseinde

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Important dates

Study start
1998
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2007
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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