Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients
| Tracking Information | |||||
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| First Received Date ICMJE | February 4, 2010 | ||||
| Last Updated Date | February 8, 2010 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01063296 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||
| 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 | Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients | ||||
| Official Title ICMJE | Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery | ||||
| Brief Summary | Cervical cancer is a major health problem for Chinese women. It is estimated that nearly 100,000 new cervical cancer cases occur in China every year, which accounts for about 20 percent of global new cases. Surgery and radiotherapy are two major radical treatment methods for IB-IIB cervical cancer. Unlike the United States and some other countries, most of operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN guidelines. However, in China a substantial part of patients especially those admitted to tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they had recurrence risk factors . In our previous study, we found that patients with intermediate risk factors (deep stromal invasion, positive lymphatic vascular space, bulky tumor>4cm) had better disease-free survival and recurrence-free survival when they received chemotherapy compared with radiotherapy. The objective in this study is to investigate whether the advantage of postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the patients with intermediate risk factors. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: sampling of peripheral blood |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients with histologically confirmed Ib~IIa cervical carcinoma without previous treatments |
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| Condition ICMJE | Cervical Cancer | ||||
| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2014 (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 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01063296 | ||||
| Other Study ID Numbers ICMJE | GM2010-02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Ding Ma, Cancer Biology Research Center of Tongji Hospital | ||||
| Study Sponsor ICMJE | Huazhong University of Science and Technology | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Huazhong University of Science and Technology | ||||
| 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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