Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT00568490

Conditions

Head and Neck Cancer

Lung Cancer

Lip Cancer

Lip Neoplasms

Head and Neck Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tumor biopsy

Phlebotomy

Study Details

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.

Conditions

Head and Neck Cancer

Lung Cancer

Lip Cancer

Lip Neoplasms

Head and Neck Cancers

Study ID

NCT00568490

Start date

Sep 1, 1998

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

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

Primary outcome measure

  • Identification of Secreted Markers for Tumor Hypoxia through tissue collection [ Time Frame: before therapy, weekly during therapy ]

Central Contacts and Locations

Central contacts

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Cancer Clinical Trials Office

(650) 498-7061

Principal Investigator:

Quynh-Thu Le

More Information

Sponsor

Stanford University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-01.