A Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy
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| First Received Date ICMJE | April 16, 2009 | ||||
| Last Updated Date | January 25, 2013 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To describe incidence of Febrile Neutropenia (FN) based on Granulocyte Colony Stimulating Factor (G-CSF) (primary, secondary or no usage) use in subjects receiving myelotoxic chemotherapy. [ Time Frame: The duration of the G-CSF use ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00883181 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | A Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy | ||||
| Official Title ICMJE | A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy | ||||
| Brief Summary | This is a multi center international observational study of subjects receiving myelotoxic regimens, with an investigator assessed risk of Febrile Neutropenia (FN) ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung). Approximately 100-150 sites will contribute information on 10-15 subjects treated at their institution. |
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| Detailed Description | This is a multi center international observational study of subjects receiving myelotoxic regimens, with an investigator assessed risk of FN ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung). Approximately 100-150 sites will contribute information on 10-15 subjects treated at their institution. Sites will be selected where the data specified below is routinely collected for patient management. The selection of sites will be managed to try and represent a selection of various treating centers within each country. However, whilst sites will be encouraged to provide data on patients with all tumor types this will not be enforced and sites or indeed countries may enroll patients to only 1 tumor group. The reason for any site not wishing to participate will be recorded and reported at study end. Approximately 1300 subjects will be recruited . The aim is to have approximately 800 breast cancer, 300 Non-Small Cell Lung Cancer, 100 Small-Cell Lung Cancer and 100 ovarian cancer subjects. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: This is an observational study. No bio-specimens are being collected. |
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| Sampling Method | Probability Sample | ||||
| Study Population | Subjects greater than or equal to 18 years old. Subjects with breast, ovarian or lung cancer. Subjects receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy. Subjects with Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines). Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study). Written subject consent (where required by local law). |
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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 | Active, not recruiting | ||||
| Enrollment ICMJE | 1370 | ||||
| Estimated Completion Date | November 2014 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study). |
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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 | NCT00883181 | ||||
| Other Study ID Numbers ICMJE | 20060445 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Amgen | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | January 2013 | ||||
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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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