Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
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ClinicalTrials.gov Identifier: NCT00568490 |
Recruitment Status :
Recruiting
First Posted : December 6, 2007
Last Update Posted : June 14, 2022
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Condition or disease | Intervention/treatment |
---|---|
Head and Neck Cancer Lung Cancer Lip Cancer Lip Neoplasms Head and Neck Cancers | Procedure: Tumor biopsy Procedure: Phlebotomy |
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 Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers |
Actual Study Start Date : | September 1, 1998 |
Estimated Primary Completion Date : | June 15, 2023 |
Estimated Study Completion Date : | December 15, 2023 |

- 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 UniversityOther Name: Blood draw
- Identification of Secreted Markers for Tumor Hypoxia through tissue collection [ Time Frame: before therapy, weekly during therapy ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568490
Contact: Rachel Freiberg | rachelf@stanford.edu |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Rachel Freiberg 650-725-0438 rachelf@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: Quynh-Thu Le | |
Sub-Investigator: Amato Giaccia | |
Sub-Investigator: Richard L Goode | |
Sub-Investigator: Harlan Pinto | |
Sub-Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D. |
Principal Investigator: | Quynh-Thu Le | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00568490 |
Obsolete Identifiers: | NCT00185822 |
Other Study ID Numbers: |
ENT0016 15310; CA67166 73995 ( Other Identifier: Stanford University Alternate IRB Approval Number ) SU-11052007-801 ( Other Identifier: Stanford University ) |
First Posted: | December 6, 2007 Key Record Dates |
Last Update Posted: | June 14, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Head and Neck Neoplasms Lip Neoplasms Hypoxia Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Signs and Symptoms, Respiratory Mouth Neoplasms Lip Diseases Mouth Diseases Stomatognathic Diseases |