Trial document




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  DRKS00011420

Trial Description

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Title

Study on intensified follow-up care for malign neoplasma of the mammary gland under self-anamnesis

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Trial Acronym

SiNaB

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URL of the Trial

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Brief Summary in Lay Language

The study compares various ways of follow-up care for breast cancer patients in Bremen. Aim of the study is the improvement of the actual follow-up-care for breast cancer patients in Bremen.
The target patient group is formed by patients insured at the AOK Bremen/Bremerhaven aged between 30 and 50 years with a malign neoplasm of the mammary gland who will receive an intensified follow-up care beyond standard in order to allow early detection of an additional neoplasm of the mammary gland. The new intensified follow-up care comprises
(i) Periodical self-examination of the breast according to medical instruction
(ii) Every 6 months: examination by palpation of the breast
(iii) Every 12 months: ultrasonic testing, 2D and 3D mammography, magnetic resonance tomography (MRT, with and without contrast medium)
The attending radiologist provides an assessment of ultrasonic testing, mammography (2D and 3D), and magnetic resonance tomography with contrast medium. The joint assessment is the basis for the subsequent medical treatment.
As the use of a contrast medium implies a certain risk, avoidance of a contrast medium would be advantageous for future examinations. To check if avoiding a contrast medium can be done without disadvantage for the patient is one aim of this study. For this reason, this study generates additional MRT images without using a contrast medium. Images made with and without contrast medium are assessed by 3 different radiologists independently from another and without knowledge of the clinical findings or the patient („blinded“). If the findings obtained with and without contrast medium were in good agreement, the use of a contrast medium could be avoided in future.
The MRT images made without contrast medium are generated for the purpose of this study only. They and the additional diagnoses by 2 additional radiologists have no impact on the clinical treatment of the patient by the attending radiologist.
A second aim of the study is to check if a 3 dimensional (3D) imaging of the breast is advantageous compare to 2D imaging. Both versions of imaging can be obtained from the same basic image, which means that no additional imaging is required for the 2D image. Patients need not exposed to an additional radiation for the 2D image.
All study participants enjoy after an initial examination and interview an intensified follow-up care over 12 months. This provides 2 MRT and mammography images for each participant.
If the disease returns (a relapse occurs) a
One year after the second follow-up examination the patient will be asked if the disease has returned (a relapse occurred). If so, the attending gynaecologist will be asked for the date of the relapse and, if a tissue sample was taken, for the result of its examination. This has the purpose to better understand the course of the disease. It is done only if the patient has expressed her consent to this action.
In the course of and after the study the patients receive their usual treatment by their attending physician. Therapeutic recommendations will rely only on examinations and assessments that are part of the intensified programme detailed under (i) – (iii). Assessments of additional images by study physicians generated for the purpose of this study are left out of consideration for therapeutic recommendations.

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Brief Summary in Scientific Language

This study investigates the exchangeability and reliability of diagnoses on the basis of several image-based procedures (MRT with and without contrast medium, mammography). The study runs as part of a breast cancer follow-up care programme for high risk patients.
The primary study aim is to check the exchangeability of MRTassessments with and without contrast medium. This is done by calculating the one-sided 95% confidence interval of the difference between coefficients of agreement (agreement of results from MRT with/without contrast medium compared to agreement of results from MRT with/with contrast medium). If the confidence interval does not include the non-inferiority margin of 4%, it will be concluded that assessments with or without contrast medium can be exchanged without relevant reduction of the inter-rater agreement.
The secondary study aim is to quantify the reliability of BI-RADS classifications based on 2D images with the reliability of classifications based on 3D imaging.

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Organizational Data

  •   DRKS00011420
  •   2016/12/21
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  •   yes
  •   Approved
  •   RE-546, Ethik-Kommission der Ärztekammer Bremen
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Secondary IDs

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Health Condition or Problem studied

  •   C50.0 -  Malignant neoplasm: Nipple and areola
  •   Z85.3 -  Personal history of malignant neoplasm of breast
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Interventions/Observational Groups

  •   Patients are subjected to routine MRI / mammography / ultrasound examinations. MRI diagnosis is performed for comparison with and without contrast. Mammography is used for comparison in 2D and 3D. All images of mammography and the MRI are blinded to the reader with a pseudocode before the evaluation.
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Reliability of the MRI image assessment with and without contrast media

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Secondary Outcome

Reliability of the assessment of mammography images (2D vs. 3D)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2017/01/03
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   30   Years
  •   50   Years
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Additional Inclusion Criteria

Female insured members of the AOK Bremen / Bremerhaven at the age of 30 - 50 years
• Diagnosis according to ICD-10-GM 2016: C 50.0 - 9 Malignant neoplasm of the mammary gland or Z85.3 Malignant neoplasm of the mammary gland in its own anamnesis
• Disease already in remission
• Written consent to participate in the study ("informed consent")

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Exclusion Criteria

• Mastectomy (OPS 5-870, 5-874, 5-877, 5-872)

• Existing pregnancy

• Contrast agent allergy

• Overactive thyroid

• planned change of residence within the intervention period

• Absolute and relative contraindications against magnetic resonance tomography of the breast (eg iron-containing material in the body, heart pacemaker)

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Addresses

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    • St. Joseph-Stift Bremen
    • Mr.  Torsten  Jarchow 
    • Schwachhauser Heerstraße 54
    • 28209  Bremen
    • Germany
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    • Institut für Radiologische DiagnostikSt. Joseph-Stift
    • Mr.  Prof. Dr.  Felix  Diekmann 
    • Schwachhauser Heerstr. 54
    • 28209  Bremen
    • Germany
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    • St. Josrph-StiftInstitut für Diagnotische Diagnose
    • Mr.  Prof. Dr.  Felix  Diekmann 
    • Schwachhauser Heerstr. 64
    • 28209  Bremen
    • Germany
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Sources of Monetary or Material Support

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    • AOK Bremen/Bremerhaven
    • Ms.  Berg  Julia 
    • Bürgermeister-Smidt-Str. 95
    • 28195  Bremen
    • Germany
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    • St. Joseph-Stift Bremen
    • Mr.  Torsten  Jarchow 
    • Schwachhauser Heerstraße 54
    • 28209  Bremen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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