Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
This study is currently recruiting participants.
Verified August 2010 by Beijing Cancer Hospital
Sponsor:
Beijing Cancer Hospital
Information provided by:
Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01198301
First received: September 9, 2010
Last updated: July 21, 2011
Last verified: August 2010
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| First Received Date ICMJE | September 9, 2010 | ||||||||
| Last Updated Date | July 21, 2011 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Chemotherapy response [ Time Frame: four-months ] [ Designated as safety issue: Yes ] Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines |
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| Original Primary Outcome Measures ICMJE |
Chemotherapy response [ Time Frame: Chemotherapy response is evaluated after two cycles of chemotherapy ] [ Designated as safety issue: Yes ] Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines |
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| Change History | Complete list of historical versions of study NCT01198301 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy | ||||||||
| Official Title ICMJE | Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy | ||||||||
| Brief Summary | The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer. |
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| Detailed Description |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: the tissue will be obtained by core niddle biopsy. |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | female patients with metastatic breast cancer treated by Docetaxel-based chemotherapy |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01198301 | ||||||||
| Other Study ID Numbers ICMJE | GEP | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jun Ren/Director of the Medical Oncology Department, Beijing Cancer Hospital | ||||||||
| Study Sponsor ICMJE | Beijing Cancer Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Beijing Cancer Hospital | ||||||||
| Verification Date | August 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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