Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor biopsy, Phlebotomy.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Lung Cancer, Lip Cancer, Lip Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- Identification of Secreted Markers for Tumor Hypoxia through tissue collection [Time frame: before therapy, weekly during therapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Stanford University School of Medicine — Stanford
Identifiers
NCT: NCT00568490 · IRB-10564 · 73995 · SU-11052007-801 · R01DE029672-01A1