Trial document




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  DRKS00019043

Trial Description

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Title

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

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Trial Acronym

TIDO-NIS

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URL of the Trial

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Brief Summary in Lay Language

In the first step of the study, this study examines the frequency with which iron deficiency can be detected in patients who enter a oncological practice for the first time with a malignant tumor disease. The iron deficiency is checked by different blood laboratory values. If a new cancer therapy is pending in the patients and an iron deficiency with a saturation value for the laboratory value Transferrin of <20% and with a laboratory value ferritin of 100 - 800 ng / ml is found, the treating oncologist can decide, whether the iron deficiency by a dose of Iron carboxymaltose should be balanced across the vein. If he decides to administer such a dose and administers iron carboxymaltose, the patients can then be followed up in the second examination step over a period of 12 weeks with various examinations (laboratory tests and queries about the quality of life or general well-being). The aim of this study is to investigate whether the iron deficiency balance improves the laboratory values ​​and the results of cancer therapy as well as the quality of life under cancer therapy. The tests to be performed correspond to the daily routine, so that no additional services are initiated.

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Brief Summary in Scientific Language

Iron deficiency is a common comorbidity in the general population. Iron deficiency anemia is highly prevalent in the oncological population, nevertheless systematic data on isolated iron deficiency in this specific population are lacking. Anemia directly impacts the outcome of primary disease treatment by putting the patients at risk of interrupting or decreasing chemo therapy dose. In inflammatory conditions, e.g. cancer, current publications recommend therapeutic intervention at the stage of iron deficiency, before the development of anemia. Limitations of ferritin as a diagnostic marker, especially in chronic or inflammatory conditions, have been demonstrated, suggesting TSAT as a diagnostic marker for iron deficiency and putative treatment trigger. Therefore, this two-step study will evaluate the prevalence of iron deficiency in an unselected oncological population and, secondly, analyse possible benefits of treatment with i.v. ferric carboxymaltose in the iron deficient oncological population in routine practice.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019043
  •   2019/10/17
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  •   no
  •   Approved
  •   2019283, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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Health Condition or Problem studied

  •   E61.1 -  Iron deficiency
  •   D50.0 -  Iron deficiency anaemia secondary to blood loss (chronic)
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Interventions/Observational Groups

  •   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 <20% and ferritin <800 ng / ml and onset of drug tumor therapy and decision of the oncologist to compensate for iron deficiency by intravenous Eisencarboxymaltose the patient is then in a monitoring period of 12 weeks with respect to development of laboratory values, the quality of life, the general health conditions and the success of the tumor therapy tracked.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/10/20
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Vifor Pharma Deutschland GmbH
    • Mr.  Dr.med.  Berno  Müller 
    • Baierbrunner Straße 29
    • 81379  München
    • Germany
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    • MV-Zentrum für Hämatologie und Onkologie
    • Mr.  Dr. med.  H.Tilman  Steinmetz 
    • Am Sachsenring 69
    • 50677  Köln
    • Germany
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    • GermanOncology GmbH
    • Mr.  Dr.med.  Rainer  Lipp 
    • Überseeallee 1
    • 20457  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Vifor Pharma Deutschland GmbH
    • BaierbrunnerStraße 29
    • 81379  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.