Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by Stanford University
Sponsor:
Stanford University
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00568490
First received: December 4, 2007
Last updated: July 11, 2016
Last verified: July 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer Lung Cancer Lip Cancer Lip Neoplasms Head and Neck Cancers |
Procedure: Tumor biopsy Procedure: Phlebotomy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Identification of Secreted Markers for Tumor Hypoxia through tissue collection [ Time Frame: before therapy, weekly during therapy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
blood, tumor tissue
| Estimated Enrollment: | 600 |
| Study Start Date: | September 1998 |
| Estimated Study Completion Date: | April 2022 |
| Estimated Primary Completion Date: | April 2022 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
Other Name: Blood draw
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Newly diagnosed patients with head and neck cancer
Criteria
Inclusion Criteria:Newly diagnosed patients with head and neck cancer who has tumor accessible to tumor oxygenation measurement with a microelectrode.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568490
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568490
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Amanda Simmons 650-724-4606 amandals@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. | |
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
| Principal Investigator: | Quynh-Thu Le | Stanford University |
More Information
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00568490 History of Changes |
| Obsolete Identifiers: | NCT00185822 |
| Other Study ID Numbers: | ENT0016 15310; CA67166 73995 SU-11052007-801 |
| Study First Received: | December 4, 2007 |
| Last Updated: | July 11, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Head and Neck Neoplasms Lip Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Mouth Neoplasms Lip Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on September 30, 2016