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

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 - TIDO-NIS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00019043

Enrollment

800

Registered

2019-10-17

Start date

2019-10-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E61.1 D50.0

Interventions

Group 1: Phase 1: Patients with malignant tumors are screened for the presence of iron deficiency or iron deficiency anemia by various parameters (TSAT, ferritin, hemoglobin, etc.). Phase 2: At TSAT <

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Step 1: 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. Step 2: 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.	—

Measure

Time frame

Step 1: 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. Step 2: 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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactRainer Lipp

GermanOncology GmbH

lipp@germanoncology.de+49 40 5589742220

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026