Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (D.O.S.E. Registry)

This study is enrolling participants by invitation only.

First Received: September 13, 2005 Last Updated: February 27, 2009 History of Changes

Sponsor:	Ortho Biotech Products, L.P.
Information provided by:	Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:	NCT00212862

Purpose

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; i.e. epoetin alfa or darbepoetin alfa)

Condition
Epoetin Alfa Cancer Anemia Darbepoetin Alfa

Study Type:	Observational
Study Design:	Prospective
Official Title:	Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer

U.S. FDA Resources

Further study details as provided by Ortho Biotech Products, L.P.:

Estimated Enrollment:

1200

Detailed Description:

DOSE is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with epoetin alfa or darbepoetin alfa. 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.

N/A

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults (18 years of age or older) with cancer who are being treated with an erythropoiesis-stimulating therapy for anemia of cancer or cancer-related treatment
The patient must speak and read English and be able to answer the type of simple questions presented in the patient questionnaires
The patient must consent to participate in the registry by signing the informed consent form

Exclusion Criteria:

No epoetin alfa or darbepoetin alfa within 90 days prior to study entry
Not currently participating in any other clinical study of EST (however, the patient may be undergoing treatment under an investigational cancer treatment protocol)
No current or previous history of dialysis for end stage renal disease
No known myelodysplasia or any myelodysplastic syndrome
Not known to need stem cell transplant
No self-administration of epoetin alfa or darbepoetin alfa

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212862

Sponsors and Collaborators

Ortho Biotech Products, L.P.

Investigators

Study Director:

Ortho Biotech Products, L.P. Clinical Trial

Ortho Biotech Products, L.P.

More Information

Publications:

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.

Study ID Numbers:	CR004561
Study First Received:	September 13, 2005
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00212862 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ortho Biotech Products, L.P.:

epoetin alfa
cancer
anemia
darbepoetin alfa

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on February 08, 2010