Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | December 4, 2007 | ||||
| Last Updated Date | May 16, 2012 | ||||
| Start Date ICMJE | February 2004 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00568360 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer | ||||
| Official Title ICMJE | Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer | ||||
| Brief Summary | Endoscopy is a standard part of the evaluation of patients with head and neck cancer used for determining the extent of tumor involvement. However, not all areas involved by tumor are apparent visually. Preliminary results indicate that compared with normal tissues, tumors have abnormal levels of capillary oxygenation. The purpose of this study is to determine the ability of non-pulsatile visible light tissue oxygen monitoring to differentiate normal and tumor tissue based on capillary oxygenation during endoscopy Should this be possible, this method could be used to mark tumor extent and invasion, even when that invasion is up to 5mm blow the tissue surface. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All patients with newly diagnosed head and neck cancer as well as those being seen for routine follow up with no evidence of current disease and healthy volunteers are eligible for this study. |
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| Condition ICMJE | Head and Neck Cancer | ||||
| Intervention ICMJE | Device: Oximeter | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:All patients with newly diagnosed head and neck cancer as well as those being seen for routine follow up with no evidence of current disease and healthy volunteers are eligible for this study. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00568360 | ||||
| Other Study ID Numbers ICMJE | ENT0014, 79938, SU-11062007-817 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Stanford University | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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