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

Recruiting

• Conditions: Lung Cancer; Head and Neck Cancers; Head and Neck Cancer; Lip Neoplasms; Lip Cancer

• Registration Number: NCT00568490
• Lead Sponsor: Stanford University

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.

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 Timeline

• Study Start: 1998-09-01
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of Secreted Markers for Tumor Hypoxia through tissue collection	before therapy, weekly during therapy

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States