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| Tracking Information | |||||
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| First Received Date ICMJE | May 15, 2007 | ||||
| Last Updated Date | May 15, 2007 | ||||
| Start Date ICMJE | December 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Immune reactivity [ Time Frame: Acute evaluations ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preoperative NSAID to Colorectal Cancer Patients | ||||
| Official Title ICMJE | Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions | ||||
| Brief Summary | The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer. |
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| Detailed Description | Study and control patients are randomized to receive preoperative treatment with indomethacin or celecoxib compared to sham treatment.Tumor biopsies are taken at operation and used for analyses of tumor immunity and gene expression. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Drug: Indomethacin, celecoxib, esomeprazole | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 28 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00473980 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | kl4501122 | ||||
| Study Sponsor ICMJE | Göteborg University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Göteborg University | ||||
| Verification Date | May 2007 | ||||
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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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