TSAT as a diagnostic marker for Iron Deficiency in oncological patients – prevalence of iron deficiency and effectiveness as well as tolerability of treatment with ferric carboxymaltose (FCM): a two-step non-interventional study

Completed

• Conditions: E61.1; D50.0; Iron deficiency; Iron deficiency anaemia secondary to blood loss (chronic)

• Registration Number: DRKS00019043
• Lead Sponsor: Vifor Pharma Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-17
• Study Completion: 2021-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

Step 1:
- Age over 18 years
- Proven malignant solid or hematologic tumor disease
- first contact in an oncological doctor's office
- Written consent of the patient to participate in the study incl. Data usage in compliance with the Data Protection Act (BDSG)

Step 2:
- Newly initiated systemic treatment with antitumour therapy and expected treatment duration of more than 12 weeks
- administration of systemic antitumor therapy in the participating physician practice
- Life expectancy of more than 12 weeks
- Regulation of iron carboxymaltose before the beginning of the treatment phase by the attending oncologist, regardless of participation in the study and taking into account local medical practice and local authorization.
- Patients' willingness to fill in quality of life questionnaires and well-being information over a 12-week period

Exclusion Criteria

- Known contraindication to the administration of iron carboxymaltose according to the latest product information
- Detection of myelodysplastic syndrome, myeloproliferative neoplasia or acute melodic leukemia

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Step 1:<br>Prevalence of iron deficiency, defined as evidence of transferrin saturation <20%, in patients with oncological or hematologic disease on first contact in an oncology practice.<br>Step 2:<br>Measurement of transferrin saturation (TSAT) and hemoglobin (Hb) in the course of administration of iron carboxymaltose in patients with active oncological disease and systemic antitumor therapy at baseline values of TSAT <20% and serum ferritin <800 ng / ml, and evaluation of Increase in TSAT and hemoglobin compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Step 1:<br>- Analysis of the ratio of iron deficiency to iron deficiency anemia.<br>- Analysis of iron deficiency frequency in different tumor groups<br><br>Step 2:<br>- Analysis of iron parameters over a course of 12 weeks after administration of intravenous iron carboxymaltose.<br>- Development of quality of life including fatigue over a course of 12 weeks after administration of intravenous iron carboxymaltose and during antitumor therapy.<br>- Measurement of the outcome measures of the primary antitumor therapy after administration of intravenous iron carboxymaltose.<br>- Review of the safety profile after administration of intravenous iron carboxymaltose