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Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia

Information source: Ortho Biotech Products, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia; Cancer

Intervention: Patients with chemotherapy induced anemia (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Ortho Biotech Products, L.P.

Official(s) and/or principal investigator(s):
Ortho Biotech Products, L.P. Clinical Trial, Study Director, Affiliation: Ortho Biotech Products, L.P.

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).

Clinical Details

Official title: Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: To document patient characteristics and patterns of clinical management

Secondary outcome:

To assess the relationships between patient characteristics, treatment patterns and outcomes

To measure economic impacts, and quality of life

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Additional Information

Starting date: December 2003
Last updated: June 27, 2014

Page last updated: August 23, 2015

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