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

NCT00568490 | Recruiting

• 4 other identifiers: IRB-1056473995SU-11052007-801R01DE029672-01A1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Identification of Secreted Markers for Tumor Hypoxia through tissue collection

  before therapy, weekly during therapy

Interventions

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

Also known as: Blood draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed patients with head and neck cancer

You may qualify if:

• 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

You may not qualify if:

• Refuse or unable to sign an IRB approved consent form.
• Refuse to be contacted in the future for follow up.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, tumor tissue

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Lip Neoplasms

Interventions

Phlebotomy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mouth Neoplasms; Lip Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Quynh-Thu Le

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyiwunmi Laseinde

CONTACT

Rad-onc-ccto@lists.stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: September 1, 1998
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

US (1)