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| ID | Type | Description | Link |
|---|---|---|---|
| ABT-OP-03-02 | Other Identifier | Ortho Biotech Products, L.P. |
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The purpose of this study is to describe patient characteristics, treatment patterns, and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy (EST).
The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (DOSE) is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with EST; eg, epoetin alfa or darbepoetin alfa. The planned duration of the DOSE Registry is three years. Based on initial results, the registry sponsor may elect to extend the duration of the registry.This study does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on baseline patient characteristics, treatment patterns, and clinical outcomes. Baseline determinations will include patient demographics, tumor and treatment type, hematologic parameters, and patient reported outcomes. Data will be collected over the 16-week study period with regard to EST treatment, hematologic outcomes and patient reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chemotherapy induced anemia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with chemotherapy induced anemia | Other | Physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the database. Patients will have to fill the questionaire at the time of enrollment and baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| To document patient characteristics and patterns of clinical management | The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the relationships between patient characteristics, treatment patterns and outcomes | Up to 3 years | |
| To measure economic impacts, and quality of life | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are being treated with an erythropoiesis-stimulating therapy for chemotherapy induced anemia.
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| Name | Affiliation | Role |
|---|---|---|
| Ortho Biotech Products, L.P. Clinical Trial | Ortho Biotech Products, L.P. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18266401 | Result | Larholt K, Pashos CL, Wang Q, Bookhart B, McKenzie RS, Piech CT. Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) : a registry for characterizing anaemia management and outcomes in oncology patients. Clin Drug Investig. 2008;28(3):159-67. doi: 10.2165/00044011-200828030-00003. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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