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

NCT ID: NCT00568490

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-09-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Other Intervention Names

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Blood draw

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Quynh-Thu Le

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eyiwunmi Laseinde

Role: CONTACT

Facility Contacts

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Eyiwunmi Laseinde

Role: primary

Cancer Clinical Trials Office

Role: backup

(650) 498-7061

Other Identifiers

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73995

Identifier Type: OTHER

Identifier Source: secondary_id

SU-11052007-801

Identifier Type: OTHER

Identifier Source: secondary_id

R01DE029672-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-10564

Identifier Type: -

Identifier Source: org_study_id

NCT00185822

Identifier Type: -

Identifier Source: nct_alias

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