Head and Neck CancerNCT00568490
Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
An observational study of Head and Neck Cancer and Lung Cancer, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Lip Cancer
- What is being tested?
- Tumor biopsy and Phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 1998to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed patients with head and neck cancer
Who may be able to join
- 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
Who cannot join
- Refuse or unable to sign an IRB approved consent form.
- Refuse to be contacted in the future for follow up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eyiwunmi Laseinde contact
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Eyiwunmi Laseinde, Rad-onc-ccto@lists.stanford.edu
Cancer Clinical Trials Office, (650) 498-7061
About this study
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.
Read the detailed description
The endpoints of the study are
- 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.
- To identify a gene and protein signature for hypoxia in H\&N and lung cancer patients.
- Being tested
- Tumor biopsy, Phlebotomy
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Lip Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyProcedure or surgery
For patients who undergo tumor biopsy or resection at Stanford, approximately 500 mg of the tumor will be removed from the resection specimen
PhlebotomyProcedure or surgery
Also called Blood draw
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Secreted Markers for Tumor Hypoxia through tissue collection
Measured: before therapy, weekly during therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study start1 Sep 1998
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Quynh-Thu Le, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568490
- Sponsor's protocol ID
- IRB-10564
- Other IDs
- 73995, SU-11052007-801, R01DE029672-01A1
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2007
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
- ClinicalTrials.gov ID
- NCT00568490
- Acronym / sponsor ID
- IRB-10564
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 Sep 1998 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- To identify a gene and protein signature for hypoxia in H\&N and lung cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed patients with head and neck cancer
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Refuse or unable to sign an IRB approved consent form.
- Refuse to be contacted in the future for follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor biopsyFor patients who undergo tumor biopsy or resection at Stanford, approximately 500 mg of the tumor will be removed from the resection specimen | Procedure or surgery | – |
| PhlebotomyAlso: Blood drawBlood 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 | Procedure or surgery | – |
Primary outcome
Identification of Secreted Markers for Tumor Hypoxia through tissue collection
Time frame: before therapy, weekly during therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eyiwunmi Laseinde contact
Quynh-Thu Le principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Lung Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eyiwunmi Laseinde (Rad-onc-ccto@lists.stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Secreted Markers for Tumor Hypoxia through tissue collection (time frame: before therapy, weekly during therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.