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

NCT00212862 | Completed

• 2 other identifiers: CR004561ABT-OP-03-02
• Study Type: observational
• Target: 2,130
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anemia; Cancer

Keywords

Anemia; Cancer; Epoetin alfa; Darbepoetin alfa; Registry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (1)

Patients with chemotherapy induced anemia

Other: Patients with chemotherapy induced anemia

Interventions

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.

Patients with chemotherapy induced anemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are being treated with an erythropoiesis-stimulating therapy for chemotherapy induced anemia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortho Biotech Products, L.P.: lead

Related Publications (1)

• 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.

  PMID: 18266401 RESULT

MeSH Terms

Conditions

Anemia; Neoplasms

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ortho Biotech Products, L.P. Clinical Trial

  Ortho Biotech Products, L.P.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 30, 2014

Record last verified: 2014-06