AnemiaTARNCT01795690
Clinical Tumor Anemia Registry (TAR)
An observational study of Anemia, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- How many people
- 1,018 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Feb 2016
- 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 with malignant diseases starting anti-anemic treatment
Who may be able to join
- Histologically confirmed malignant disease
- Hemoglobin level < 11 g/dl (female) or < 12 g/dl (male)
- Start of antianemic therapy no more than 7 days prior to informed consent
- Performance status 0 - 3 (Karnofsky-Index >= 40%)
- Minimum age: 18 years
- Informed written consent
Who cannot join
- Hypersensitivity against antianemic therapies
- Myelodysplastic Syndrome
- Experimental antianemic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Registry Describing Treatment Reality of Patients With Cancer-(Therapy)-Induced Anemia
The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of different treatments will be analyzed.
- Conditions
- Anemia
- Keywords
- Anemia, Cancer, Hemoglobin, Quality of Life, FACT-An, FACT-GP, Erythropoiesis-Stimulating Agents (ESA), Epoetin, Ferric Carboxymaltose, Blood Transfusions
- Medical subject headings
- Anemia, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of therapies
Overview on the current routine treatment of anemia in cancer patients in Germany
Measured: 12 weeks per patient
Secondary outcomes (1)
Change in hemoglobin levels and QoL
Effectiveness of different antianemic treatments is investigated by measuring increase of hemoglobin levels and QoL (FACT-An and FACT-GP).
Baseline in hemoglobin (before treatment) is compared with hemoglobin levels after treatment. Each patient is followed for a maximum of 12 weeks to obtain data about the course of the treatment.
Measured: 12 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startDec 2011
- Primary completionSep 2013
- Study completionFeb 2016
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.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ASORS (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie, Rehabilitation und Sozialmedizin der Deutschen Krebsgesellschaft)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795690
- Sponsor's protocol ID
- iOM TAR
- Acronym
- TAR
- Status last verified
- Dec 2014
- First submitted
- 8 Oct 2012
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Steinmetz T, Schroder J, Plath M, Link H, Vogt M, Frank M, Marschner N. Antianemic Treatment of Cancer Patients in German Routine Practice: Data from a Prospective Cohort Study-The Tumor Anemia Registry. Anemia. 2016;2016:8057650. doi: 10.1155/2016/8057650. Epub 2016 Feb 4.
PubMed 26966573
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry Describing Treatment Reality of Patients With Cancer-(Therapy)-Induced Anemia
- ClinicalTrials.gov ID
- NCT01795690
- Acronym / sponsor ID
- TAR / iOM TAR
- Conditions
- Anemia
- Keywords
- Anemia, Cancer, Hemoglobin, Quality of Life, FACT-An, FACT-GP, Erythropoiesis-Stimulating Agents (ESA), Epoetin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- ASORS (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie, Rehabilitation und Sozialmedizin der Deutschen Krebsgesellschaft)
- Study start
- Dec 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Feb 2013 (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 registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of different treatments will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant diseases starting anti-anemic treatment
Key inclusion criteria (6 listed)
- Histologically confirmed malignant disease
- Hemoglobin level < 11 g/dl (female) or < 12 g/dl (male)
- Start of antianemic therapy no more than 7 days prior to informed consent
- Performance status 0 - 3 (Karnofsky-Index >= 40%)
- Minimum age: 18 years
Key exclusion criteria (3 listed)
- Hypersensitivity against antianemic therapies
- Myelodysplastic Syndrome
- Experimental antianemic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Documentation of therapies
Time frame: 12 weeks per patient
Overview on the current routine treatment of anemia in cancer patients in Germany
1 secondary outcome
Change in hemoglobin levels and QoL
Time frame: 12 weeks per patient
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 29 Feb 2016.
- Results publication: PubMed 26966573Steinmetz T, Schroder J, Plath M, Link H, Vogt M, Frank M, Marschner N. Antianemic Treatment of Cancer Patients in German Routine Practice: Data from a Prospective Cohort Study-The Tumor Anemia Registry. Anemia. 2016;2016:8057650. doi: 10.1155/2016/8057650. Epub 2016 Feb 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by iOMEDICO AG at 1 site in Germany.
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 6 inclusion and 3 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 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
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?
Documentation of therapies (time frame: 12 weeks per patient). 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 NCT01795690, 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 29 Feb 2016.