Anemia - Cancer RelatedNCT01736215
An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy
An observational study of Anemia - Cancer Related, run by Janssen-Cilag Ltd.,Thailand at 3 sites in Thailand.
Trial summary
The purpose of this observational study is to evaluate the predictors of response to erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the body until it kills) related anemia (decreased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia - Cancer Related
- What is being tested?
- Erythropoietin: Observational study
- How many people
- 33 participants
- Where
- 3 sitesThailand
- Study dates
- Nov 2010to Feb 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Participant with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.
Who may be able to join
- Participants with non-hematologic malignancy (cancer or other progressively enlarging and spreading tumor, usually fatal if not successfully treated)
- Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment
- Participants receiving chemotherapy
- Participants having indication and planning to receiving erythropoietin (dosage and regimen should comply with Thai FDA approval package insert)
- Participants who have given consent form
Who cannot join
- Participants with anemia due to other factors (i.e., iron, B12 or folate deficiencies, hemolysis [breakdown in red blood cells], gastrointestinal bleeding, or any active bleeding)
- Participants with previous history of erythropoietin treatment
- Participants who have received blood transfusion within 1 month before starting erythropoietin therapy
- Pregnant or breast-feeding female participants
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy
The purpose of this observational study is to evaluate the predictors of response to erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the body until it kills) related anemia (decreased number of red blood cells), receiving chemotherapy (treatment of cancer using drugs).
Read the detailed description
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to erythropoietin treatment in cancer related anemia participants receiving chemotherapy. The entire duration of study will be approximately 1 year. Participants will primarily be evaluated for achieving at least 1 gram per deciliter (g per dl) rise in hemoglobin (substance that carries oxygen and gives blood its red color) level after receiving erythropoietin treatment based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria. Response to erythropoietin treatment will also be predicted using other independent hematological (related to blood) factors like C-reactive protein (CRP - is an acute serum protein released from liver). It is associated with low hemoglobin [substance that carries oxygen and gives blood its red color] or erythropoietin [hormone secreted by kidney that helps in formation of red blood cells in bone marrow] resistance), erythropoietin (EPO), hemoglobin, hematocrit (amount of red blood cells in blood), reticulocyte (immature red blood cells) count, ferritin (a protein that stores iron and allows the body to use iron), serum iron (iron is in the blood which is bound to transferrin) and transferring iron binding capacity (TIBC), level. Number of blood transfusions and participants' safety will be monitored throughout the study.
- Conditions
- Anemia - Cancer Related
- Being tested
- Erythropoietin: Observational study
- Keywords
- Anemia - cancer related, Eprex (Erythropoietin alfa)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin: Observational studyDrug
This is an observational study. Participants receiving erythropoietin (dosage and regimen will comply with Thai Food and Drug Administration approval package insert) will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Participants with cancer related anemia | Participants with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment. Receives: Drug: Erythropoietin: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Response to Erythropoietin Treatment
Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.
Measured: 8 weeks
Secondary outcomes (8)
Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)
EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed.
Measured: Baseline
Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4
CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed.
Measured: Baseline
Serum Hemoglobin Level
Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.
Measured: Baseline, Week 1, Week 2, Week 4 and Week 8
Serum Hematocrit Level
Hematocrit is the amount of red blood cells in the blood.
Measured: Baseline, Week 1, Week 2, Week 4 and Week 8
Reticulocyte Count
Reticulocytes are immature red blood cells.
Measured: Baseline, Week 1, Week 2, Week 4 and Week 8
Serum Ferritin Level
Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron.
Measured: Baseline, Week 1 and Week 2
Serum Iron Level
Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.
Measured: Baseline, Week 1 and Week 2
Transferring Iron Binding Capacity (TIBC)
TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.
Measured: Baseline, Week 1 and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: This study was terminated regarding to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia - Cancer RelatedStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.,Thailand
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mahidol University
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd.,Thailand Clinical Trial, Study director, Janssen-Cilag Ltd.,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736215
- Sponsor's protocol ID
- CR016558
- Other IDs
- EPOCAN4028
- Status last verified
- Mar 2014
- First submitted
- 26 Nov 2012
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01736215
- Acronym / sponsor ID
- CR016558
- Conditions
- Anemia - Cancer Related
- Keywords
- Anemia - cancer related, Eprex (Erythropoietin alfa)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated regarding to slow enrollment.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.,ThailandIndustry (pharma, biotech, devices)
- Collaborators
- Mahidol University
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 30 May 2013
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 observational study is to evaluate the predictors of response to erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the body until it kills) related anemia (decreased number of red blood cells), receiving chemotherapy (treatment of cancer using drugs).
Detailed description
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to erythropoietin treatment in cancer related anemia participants receiving chemotherapy. The entire duration of study will be approximately 1 year. Participants will primarily be evaluated for achieving at least 1 gram per deciliter (g per dl) rise in hemoglobin (substance that carries oxygen and gives blood its red color) level after receiving erythropoietin treatment based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria. Response to erythropoietin treatment will also be predicted using other independent hematological (related to blood) factors like C-reactive protein (CRP - is an acute serum protein released from liver). It is associated with low hemoglobin [substance that carries oxygen and gives blood its red color] or erythropoietin [hormone secreted by kidney that helps in formation of red blood cells in bone marrow] resistance), erythropoietin (EPO), hemoglobin, hematocrit (amount of red blood cells in blood), reticulocyte (immature red blood cells) count, ferritin (a protein that stores iron and allows the body to use iron), serum iron (iron is in the blood which is bound to transferrin) and transferring iron binding capacity (TIBC), level. Number of blood transfusions and participants' safety will be monitored throughout the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with cancer related anemia | – | Drug: Erythropoietin: Observational studyParticipants with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.
Key inclusion criteria (5 listed)
- Participants with non-hematologic malignancy (cancer or other progressively enlarging and spreading tumor, usually fatal if not successfully treated)
- Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment
- Participants receiving chemotherapy
- Participants having indication and planning to receiving erythropoietin (dosage and regimen should comply with Thai FDA approval package insert)
- Participants who have given consent form
Key exclusion criteria (4 listed)
- Participants with anemia due to other factors (i.e., iron, B12 or folate deficiencies, hemolysis [breakdown in red blood cells], gastrointestinal bleeding, or any active bleeding)
- Participants with previous history of erythropoietin treatment
- Participants who have received blood transfusion within 1 month before starting erythropoietin therapy
- Pregnant or breast-feeding female participants
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 |
|---|---|---|
| Erythropoietin: Observational studyThis is an observational study. Participants receiving erythropoietin (dosage and regimen will comply with Thai Food and Drug Administration approval package insert) will be observed. | Drug | Participants with cancer related anemia |
Primary outcome
Percentage of Participants With Response to Erythropoietin Treatment
Time frame: 8 weeks
Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.
8 secondary outcomes
Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)
Time frame: Baseline
Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4
Time frame: Baseline
Serum Hemoglobin Level
Time frame: Baseline, Week 1, Week 2, Week 4 and Week 8
Serum Hematocrit Level
Time frame: Baseline, Week 1, Week 2, Week 4 and Week 8
Reticulocyte Count
Time frame: Baseline, Week 1, Week 2, Week 4 and Week 8
Serum Ferritin Level
Time frame: Baseline, Week 1 and Week 2
Serum Iron Level
Time frame: Baseline, Week 1 and Week 2
Transferring Iron Binding Capacity (TIBC)
Time frame: Baseline, Week 1 and Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anemia - Cancer Related
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia
Fanconi Anemia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Not yet recruitingPhase 2
A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy
Chemotherapy Induced Anemia
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.
Janssen-Cilag Ltd.,Thailand Clinical Trial study director
Janssen-Cilag Ltd.,Thailand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia - Cancer Related, run by Janssen-Cilag Ltd.,Thailand at 3 sites in Thailand.
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 4 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: stopped early, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 30 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Response to Erythropoietin Treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2014.