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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00568490
• Other study ID #: IRB-10564
• Secondary ID: 15310; CA6716673
• Status: Recruiting
• Start date: September 1, 1998
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: Eyiwunmi Laseinde
• Email: Rad-onc-ccto[@]lists.stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00185822

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Cancers
• Head and Neck Neoplasms
• Hypoxia
• Lip Cancer
• Lip Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of Secreted Markers for Tumor Hypoxia through tissue collection		before therapy, weekly during therapy