Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer
This study has been completed.
Sponsor:
University of New Mexico
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00298064
First received: February 28, 2006
Last updated: January 6, 2010
Last verified: November 2009
| Tracking Information | |||||
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| First Received Date ICMJE | February 28, 2006 | ||||
| Last Updated Date | January 6, 2010 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | February 2008 (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 NCT00298064 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 | Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer | ||||
| Official Title ICMJE | Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer | ||||
| Brief Summary | The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET) blocks. |
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| Detailed Description | This study is done to gather preliminary data for determining the best way to test EGFR expression in patients with cervical cancer who will receive treatment with EGFR inhibitors in the future. This study is designed to obtain preliminary data of genomic and phenotypic alterations of the EGFR pathway in high grade cervical intraepithelial lesions (HG-SIL) and invasive cervical cancers (CC) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the EGFR pathway. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Genetic: Tissue Repository | ||||
| Study Arm (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 | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00298064 | ||||
| Other Study ID Numbers ICMJE | INST 0548C | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Claire Verschraegen, MD; Principal Investigator, University of New Mexico | ||||
| Study Sponsor ICMJE | University of New Mexico | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of New Mexico | ||||
| Verification Date | November 2009 | ||||
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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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