NCT05190263

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,053

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

December 14, 2021

Last Update Submit

February 14, 2022

Conditions

Anemia, Iron DeficiencySolid TumorMalignant Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    06/2021 - 09/2022

Interventions

non-interventional retrospective epidemiological observational studyOTHER

non-interventional retrospective epidemiological observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with solid tumors or malignant lymphoma

You may qualify if:

  • 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.

You may not qualify if:

  • Follow up time less than 4 weeks,
  • lack of patient contact after anemia diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Studienzentrum Prof. Dr. med. Hartmut Link, Facharzt für Innere Medizin, Hämatologie und Internistische Onkologie

Kaiserslautern, 67661, Germany

Location

Related Publications (1)

  • 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.

    PMID: 38240843DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyLymphoma

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Hartmut Link, Prof. Dr.

    AIO AG Supportive Therapie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 13, 2022

Study Start

October 25, 2021

Primary Completion

February 6, 2022

Study Completion

February 6, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

DE(1)