Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | June 19, 2009 | ||||||||||||||||
| Last Updated Date | October 31, 2012 | ||||||||||||||||
| Start Date ICMJE | July 2007 | ||||||||||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00926315 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Follow-up for 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation | ||||||||||||||||
| Official Title ICMJE | Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients | ||||||||||||||||
| Brief Summary | The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients. |
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| Detailed Description | Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts. Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Experimental: calcitriol
calcitriol supplementation (0.25 mcg 2x/d)
Interventions:
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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 | Active, not recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||||||||||
| Estimated Completion Date | December 2013 | ||||||||||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||||||
| Ages | 40 Years to 70 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Brazil | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00926315 | ||||||||||||||||
| Other Study ID Numbers ICMJE | FMUSPIBCCVD2009, CAPPesq 626/06, FAPESP 07/04799-2, IBCC 108/2006/07, CAPPesq 0018/09 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital | ||||||||||||||||
| Study Sponsor ICMJE | University of Sao Paulo General Hospital | ||||||||||||||||
| Collaborators ICMJE | Instituto Brasileiro de Controle do Cancer | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo General Hospital | ||||||||||||||||
| Verification Date | October 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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