Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 18, 2010 | ||||
| Last Updated Date | January 18, 2010 | ||||
| Start Date ICMJE | July 2007 | ||||
| Estimated Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Response rate, progression-free survival and over-all survival [ Time Frame: 4 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Quantification of CTCs [ Time Frame: 4 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer | ||||
| Official Title ICMJE | |||||
| Brief Summary | The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients |
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| Detailed Description | In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Biospecimen | Retention: Samples With DNA Description: Peripheral blood samples are collected were the cell pellet are collected from centrifugation, lysed by TRIzol method to get RNA. The RNA is retrotranscribed to cDNA in order to quantify cytokeratin (CK) 19, 18 and carcinoembrionic antigen which are markers of epithelial cells presumambly coming form the tumor. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Advanced non small-cell lung cancer |
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| Condition ICMJE | Circulating Tumor Cells | ||||
| Intervention ICMJE | |||||
| Study Group/Cohort (s) | Stage IV NSCLC
Stage IV non small-cell lung cancer patients will be recruited for this protocol |
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| Publications * | |||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Non-advanced disease |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Mexico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01052818 | ||||
| Other Study ID Numbers ICMJE | INCAN/OfCA204/SO151/CB451/09, 87453 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Oscar Arrieta Rodriguez, CONACyT | ||||
| Study Sponsor ICMJE | National Institute of Cancerología | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Cancerología | ||||
| Verification Date | January 2010 | ||||
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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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