Status:
COMPLETED
Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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).
Detailed Description
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 E...
Eligibility Criteria
Inclusion
- Patients with cancer who are being treated with an erythropoiesis-stimulating therapy (EST) for anemia of cancer or cancer-related treatment
- Must be EST ''naive'' globally or must have been off treatment with an EST for at least 90 days
- Must speak and read english and be able to answer the type of simple questions presented in the patient questionnaires
- If the patient is identified for the study while an inpatient, they must be able to be followed for up to 16 weeks
- The patient must give consent to participate in the registry by signing the informed consent form
Exclusion
- Patients currently participating in any other clinical study of EST (however, the patient may be undergoing treatment under an investigational cancer treatment protocol)
- Have or had been on dialysis for end stage renal disease in the past
- Has myelodysplasia or any myelodysplastic syndrome
- Patients are known to need stem cell transplant
- Patient who will self-administer the epoetin alfa or darbepoetin alfa
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
2130 Patients enrolled
Trial Details
Trial ID
NCT00212862
Start Date
December 1 2003
End Date
July 1 2009
Last Update
June 30 2014
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