Anemia, Iron DeficiencyQA AnemiaNCT05190263
Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma
An observational study of Anemia, Iron Deficiency and Solid Tumor, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
The aim of the study is to analyze the implementation of the 2018 updated ESMO Guideline in patients with tumor diseases as well as the corre-sponding recommendations of the Onkopedia Guideline and the S3 Guide-line Supportive Therapy in routine clinical practice in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron Deficiency, Solid Tumor, Malignant Lymphoma
- What is being tested?
- non-interventional retrospective epidemiological observational study
- How many people
- 1,053 participants
- Where
- 1 siteGermany
- Study dates
- 25 Oct 2021to 6 Feb 2022
- 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 solid tumors or malignant lymphoma
Who may be able to join
- Patients
- with antineoplastic therapy (chemotherapy or "new substances"), radiochemotherapy or radiotherapy in the period 1/1/2021 - 06/30/2021
- with anemia with hemoglobin levels decreases below 10g/dl (6.2 mmol/l) at least once during the period 1/1/2021 - 06/30/2021
- with at least 4 weeks of follow up period after anemia diagnosis.
Who cannot join
- Follow up time less than 4 weeks,
- lack of patient contact after anemia diagnosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Studienzentrum Prof. Dr. med. Hartmut Link, Facharzt für Innere Medizin, Hämatologie und Internistische Onkologie
Kaiserslautern, 67661
About this study
The aim of the study is to analyze the implementation of the 2018 updated ESMO Guideline in patients with tumor diseases as well as the corre-sponding recommendations of the Onkopedia Guideline and the S3 Guide-line Supportive Therapy in routine clinical practice in Germany.
To this end, a nationwide, representative, retrospective patient documen-tation will be conducted to observe the current practice of anemia man-agement in hospitals and among office-based physicians.
Read the detailed description
Health care structure analysis and recruitment (phase 1):
In a first step, data on care facilities treating patients in the above indica-tions in Germany will be collected (gastroenterology, gynecology, hema-tology/oncology, and pneumology hospital departments, as well as of-fice-based hematologists/oncologists and gynecology oncologists).
In Phase 1, all centers in Germany potentially treating patients in the above entities will be contacted and data on the care level of the institu-tion and the number of patients treated will be collected using a one-page pen-to-paper form. In addition, the willingness of the care facilities to participate in the documentation of patients will be surveyed (Phase 2).
Analysis of patient records (phase 2)
In order to obtain a reliable, representative sample of patients treated in Germany, the distribution of the cases to be documented in the individual indications among the participating facilities is determined. For this pur-pose, the data collected from the facilities in Phase I on patient numbers and treatment structure will be used:
Participating centers are divided into clusters based on key distinguishing characteristics (facility type, level of care, and number of patients treat-ed). This sample is modulated according to the previous care structure analysis. This approach allows the actual percentages of the different care facilities in an indication area to be proportionally included in the patient documentation sample.
In Phase 2, a multi-page electronic case record form (eCRF) will be com-pleted to collect patient and treatment data relevant to the purpose of the study. All data will be collected retrospectively and anonymously from patient records.
- Patient- and disease-related variables (age, ECOG performance status, staging, relevant comorbidities).
- Drug therapy (chemotherapy, antibodies, immunotherapy, kinase inhibitors: Start/end, substances or regimens).
- Radiotherapy (start/end, irradiated region)
- Laboratory diagnostics (if available) with Hb, Hk, MCV, MCH, re-ticulocytes and/or Ret-Hb, ferritin, transferrin and/or transferrin saturation (TSAT), holo-trans-cobalamin (vitamin B12), folic acid, zinc protoporphyrin, creatinine clearance (GFR), EPO level
- Data on anemia therapy (transfusion of RBC; iron therapy p.o. or i.v.; ESA). To ensure data quality, the scientific project lead will train two employees of the commissioned institute in content-related issues of the study. This knowledge will be incorporated into the programming of the user inter-face and the patient databases so that the program will check for com-pleteness and, as far as possible, plausibility based on defined require-ments and framework conditions. These checks accompany the process of data entry into the eCRF and enable immediate validation of the data.
- Conditions
- Anemia, Iron Deficiency, Solid Tumor, Malignant Lymphoma
- Being tested
- non-interventional retrospective epidemiological observational study
- Medical subject headings
- Anemia, Iron-Deficiency, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventional retrospective epidemiological observational studyOther
non-interventional retrospective epidemiological observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
See result section upon availability
The ESMO Guideline "Management of Anemia and Iron Deficiency in Patients with Cancer", updated in 2018, provides a dedicated algorithm to guide decision-making in the diagnosis and treatment of anemia in tumor patients in order to reduce anemia-related complications. This includes recommendations on
- iron therapy,
- erythropoiesis stimulating agents (ESA) and
- transfusion with red blood cells (RBC) depending on various diagnostic parameters and the respective antitumor therapy. The therapy recommendations presented correspond with the recommendations of the Onkopedia guideline on iron deficiency anemia, the S3 guideline on supportive therapy and the cross-sectional guidelines for therapy with blood components and plasma derivatives.
To this end, this study examines the common practice of adherence to the algorithm of guideline adherence by reviewing the above criteria such as iron therapy, use of ESA and RBC substitution.
Measured: 06/2021 - 09/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start25 Oct 2021
- Primary completion6 Feb 2022
- Study completion6 Feb 2022
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 Anemia, Iron DeficiencyStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Hartmut Link, MMF GmbH, AIO AG Supportivtherapie, AG Supportive Maßnahmen in der Onkologie
- Responsible party
- Sponsor
- Investigators
- Hartmut Link, Prof. Dr., Principal investigator, AIO AG Supportive Therapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190263
- Sponsor's protocol ID
- AIO-SUP-0121
- Acronym
- QA Anemia
- Status last verified
- Feb 2022
- First submitted
- 14 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is collected retrospectively and completely anonymously from patient records, no identifying characteris-tics (e.g. birth date, initial letters, pseudonym) will be collected. It is hoped that these data will assist in creating new possibilities and ways to improve the quality of treatment through further training and enhancement of the availability and transparency of the guidelines.
Publications
Link H, Kerkmann M, Holtmann L, Detzner M. Anemia diagnosis and therapy in malignant diseases: implementation of guidelines-a representative study. Support Care Cancer. 2024 Jan 19;32(2):113. doi: 10.1007/s00520-023-08267-4.
PubMed 38240843
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT05190263
- Acronym / sponsor ID
- QA Anemia / AIO-SUP-0121
- Conditions
- Anemia, Iron Deficiency, Solid Tumor, Malignant Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Prof. Hartmut Link, MMF GmbH, AIO AG Supportivtherapie, AG Supportive Maßnahmen in der Onkologie
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 6 Feb 2022 (actual)
- First posted
- 13 Jan 2022 (actual)
- 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 aim of the study is to analyze the implementation of the 2018 updated ESMO Guideline in patients with tumor diseases as well as the corre-sponding recommendations of the Onkopedia Guideline and the S3 Guide-line Supportive Therapy in routine clinical practice in Germany.
To this end, a nationwide, representative, retrospective patient documen-tation will be conducted to observe the current practice of anemia man-agement in hospitals and among office-based physicians.
Detailed description
Health care structure analysis and recruitment (phase 1):
In a first step, data on care facilities treating patients in the above indica-tions in Germany will be collected (gastroenterology, gynecology, hema-tology/oncology, and pneumology hospital departments, as well as of-fice-based hematologists/oncologists and gynecology oncologists).
In Phase 1, all centers in Germany potentially treating patients in the above entities will be contacted and data on the care level of the institu-tion and the number of patients treated will be collected using a one-page pen-to-paper form. In addition, the willingness of the care facilities to participate in the documentation of patients will be surveyed (Phase 2).
Analysis of patient records (phase 2)
In order to obtain a reliable, representative sample of patients treated in Germany, the distribution of the cases to be documented in the individual indications among the participating facilities is determined. For this pur-pose, the data collected from the facilities in Phase I on patient numbers and treatment structure will be used:
Participating centers are divided into clusters based on key distinguishing characteristics (facility type, level of care, and number of patients treat-ed). This sample is modulated according to the previous care structure analysis. This approach allows the actual percentages of the different care facilities in an indication area to be proportionally included in the patient documentation sample.
In Phase 2, a multi-page electronic case record form (eCRF) will be com-pleted to collect patient and treatment data relevant to the purpose of the study. All data will be collected retrospectively and anonymously from patient records.
- Patient- and disease-related variables (age, ECOG performance status, staging, relevant comorbidities).
- Drug therapy (chemotherapy, antibodies, immunotherapy, kinase inhibitors: Start/end, substances or regimens).
- Radiotherapy (start/end, irradiated region)
- Laboratory diagnostics (if available) with Hb, Hk, MCV, MCH, re-ticulocytes and/or Ret-Hb, ferritin, transferrin and/or transferrin saturation (TSAT), holo-trans-cobalamin (vitamin B12), folic acid, zinc protoporphyrin, creatinine clearance (GFR), EPO level
- Data on anemia therapy (transfusion of RBC; iron therapy p.o. or i.v.; ESA). To ensure data quality, the scientific project lead will train two employees of the commissioned institute in content-related issues of the study. This knowledge will be incorporated into the programming of the user inter-face and the patient databases so that the program will check for com-pleteness and, as far as possible, plausibility based on defined require-ments and framework conditions. These checks accompany the process of data entry into the eCRF and enable immediate validation of the data.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumors or malignant lymphoma
Key inclusion criteria (4 listed)
- Patients
- with antineoplastic therapy (chemotherapy or "new substances"), radiochemotherapy or radiotherapy in the period 1/1/2021 - 06/30/2021
- with anemia with hemoglobin levels decreases below 10g/dl (6.2 mmol/l) at least once during the period 1/1/2021 - 06/30/2021
- with at least 4 weeks of follow up period after anemia diagnosis.
Key exclusion criteria (2 listed)
- Follow up time less than 4 weeks,
- lack of patient contact after anemia diagnosis
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 |
|---|---|---|
| non-interventional retrospective epidemiological observational studynon-interventional retrospective epidemiological observational study | Other | – |
Primary outcome
See result section upon availability
Time frame: 06/2021 - 09/2022
The ESMO Guideline "Management of Anemia and Iron Deficiency in Patients with Cancer", updated in 2018, provides a dedicated algorithm to guide decision-making in the diagnosis and treatment of anemia in tumor patients in order to reduce anemia-related complications. This includes recommendations on * iron therapy, * erythropoiesis stimulating agents (ESA) and * transfusion with red blood cells (RBC) depending on various diagnostic parameters and the respective antitumor therapy. The therapy recommendations presented correspond with the recommendations of the Onkopedia guideline on iron deficiency anemia, the S3 guideline on supportive therapy and the cross-sectional guidelines for therapy with blood components and plasma derivatives. To this end, this study examines the common practice of adherence to the algorithm of guideline adherence by reviewing the above criteria such as iron therapy, use of ESA and RBC substitution.
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 15 Feb 2022.
- Derived from this study: PubMed 38240843Link H, Kerkmann M, Holtmann L, Detzner M. Anemia diagnosis and therapy in malignant diseases: implementation of guidelines-a representative study. Support Care Cancer. 2024 Jan 19;32(2):113. doi: 10.1007/s00520-023-08267-4.
- Individual participant dataSharing planned: No. Data is collected retrospectively and completely anonymously from patient records, no identifying characteris-tics (e.g. birth date, initial letters, pseudonym) will be collected. It is hoped that these data will assist in creating new possibilities and ways to improve the quality of treatment through further training and enhancement of the availability and transparency of the guidelines.
Related trials for Anemia, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
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.
Hartmut Link, Prof. Dr. principal investigator
AIO AG Supportive Therapie
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, Iron Deficiency and Solid Tumor, run by AIO-Studien-gGmbH 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 4 inclusion and 2 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 15 Feb 2022. 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?
See result section upon availability (time frame: 06/2021 - 09/2022). 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 NCT05190263, 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 15 Feb 2022.