AnemiaDOSENCT00212862
Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia
An observational study of Anemia and Cancer, run by Ortho Biotech Products, L.P..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Patients with chemotherapy induced anemia
- How many people
- 2,130 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are being treated with an erythropoiesis-stimulating therapy for chemotherapy induced anemia.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Dosing and Outcomes Study of Erythropoietic Stimulating Therapies
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).
Read the 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.
- Being tested
- Patients with chemotherapy induced anemia
- Keywords
- Anemia, Cancer, Epoetin alfa, Darbepoetin alfa, Registry
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with chemotherapy induced anemiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chemotherapy induced anemia | Not described Receives: Other: Patients with chemotherapy induced anemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document patient characteristics and patterns of clinical management
The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.
Measured: Up to 3 years
Secondary outcomes (2)
To assess the relationships between patient characteristics, treatment patterns and outcomes
Measured: Up to 3 years
To measure economic impacts, and quality of life
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech Products, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho Biotech Products, L.P. Clinical Trial, Study director, Ortho Biotech Products, L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212862
- Sponsor's protocol ID
- CR004561
- Other IDs
- ABT-OP-03-02
- Acronym
- DOSE
- Status last verified
- Jun 2014
- First submitted
- 13 Sep 2005
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.2165/00044011-200828030-00003.
PubMed 18266401
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing and Outcomes Study of Erythropoietic Stimulating Therapies
- ClinicalTrials.gov ID
- NCT00212862
- Acronym / sponsor ID
- DOSE / CR004561
- Keywords
- Anemia, Cancer, Epoetin alfa, Darbepoetin alfa, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,130 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chemotherapy induced anemia | – | Other: Patients with chemotherapy induced anemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are being treated with an erythropoiesis-stimulating therapy for chemotherapy induced anemia.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with chemotherapy induced anemiaPhysicians 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. | Other | Patients with chemotherapy induced anemia |
Primary outcome
To document patient characteristics and patterns of clinical management
Time frame: Up to 3 years
The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.
2 secondary outcomes
To assess the relationships between patient characteristics, treatment patterns and outcomes
Time frame: Up to 3 years
To measure economic impacts, and quality of life
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Results publication: PubMed 18266401Larholt 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho Biotech Products, L.P. Clinical Trial study director
Ortho Biotech Products, L.P.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Cancer, run by Ortho Biotech Products, L.P..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To document patient characteristics and patterns of clinical management (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.