Thai Cancer Anemia Survey in Chulalongkorn Hospital
| Tracking Information | |||||
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| First Received Date ICMJE | November 19, 2009 | ||||
| Last Updated Date | March 11, 2010 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Number of patients that have anemia during cancer therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01018043 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Characteristic of each patients example treatment duration,type and chemotherapy using, grade of anemia [ Time Frame: 6 months ] [ 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 | Thai Cancer Anemia Survey in Chulalongkorn Hospital | ||||
| Official Title ICMJE | Thai Cancer Anemia Survey in Chulalongkorn Hospital | ||||
| Brief Summary | The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population. |
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| Detailed Description | Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemoglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered |
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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 | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Anemic patients with cancer receiving chemotherapy |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Adult Cancer Patients
Tracking anemia management in Adult Cancer Patients |
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| Study Group/Cohort (s) | 001
Adult Cancer Patients Tracking anemia management in Adult Cancer Patients
Intervention: Other: Adult Cancer Patients |
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| 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 | Completed | ||||
| Enrollment ICMJE | 264 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01018043 | ||||
| Other Study ID Numbers ICMJE | CR011731, TCAS-CU-ONCO-2006 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Medical Affairs Director, Janssen-Cilag Ltd.,Thailand | ||||
| Study Sponsor ICMJE | Janssen-Cilag Ltd.,Thailand | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Janssen-Cilag Ltd.,Thailand | ||||
| Verification Date | March 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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