Trial document




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  DRKS00017491

Trial Description

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Title

Investigation of the BRAF mutation status in the pleural punctate in patients with malignant melanoma, colorectal or lung cancer, that show a BRAF mutation in the primary tumor and the comparison of the result with the conventional cytological / immunohistochemical and molecular cytology findings of the pleural punctate

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Trial Acronym

BCT-BRAF-OzD-2019

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the study is to investigate the pleural fluid using a fully automatic diagnostic system (Idylla ™ from BIOCARTIS) for the presence of a gene mutation (BRAF).
BRAF is a potential cancer gene, a gene that, as part of the genome of a cell, can promote the transition from normal growth behavior of the cell to unchecked tumor growth in the event of excessive activation. The exact name of the mutation under investigation is BRAF-V600.
BRAF has already been detected by means of another method, the so-called Next Generation Sequencing, or NGS for short, on the primary tumor or metastases of the patient.
To determine whether the pleural effusion is malignant, the lung water is examined in a pathological laboratory for malignant cells. If malignant cells can be detected, these can also be examined for the present BRAF mutation in order to select a suitable treatment. However, it is not always possible to detect malignant cells in the lung water, although the effusion is malignant.
The aim of the investigation is now the direct examination of the pleural effusion with the fully automatic diagnostic system Idylla ™ of the company BIOCARTIS.
1. It should be examined whether the BRAF-mutation is detectable in the lung water, even if no malignant cancer cells could be found
2. Since the cancer gene has already been detected with the NGS procedure on the primary tumor or a metastasis, a direct comparison of both methods (ie between the NGS procedure and the BIOCARTIS procedure) should be carried out in order to obtain a possible time advantage compared to the currently usual investigations at the primary tumor or at the metastasis.
This would allow patients to receive targeted therapy more quickly in the future.
The aim of this research is not to make a diagnosis or to prove disease-inducing predispositions.

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Brief Summary in Scientific Language

The aim of this study is to investigate the pleural effusion of patients with malignant melanoma, mCRC or NSCLC, and proven BRAF-V600 mutation of the primary tumor using the Idylla ™ ctBRAF mutation assay.
The results thus obtained will be compared with the conventional cytological / immunocytological and molecular cytological cytopathological / molecular cytogenetic findings obtained during the routine examination.
The study will evaluate whether the use of the Idylla ™ ctBRAF mutation assay can detect a BRAF-V600 mutation in pleural effusion on ctDNA if the primary tumor already has this mutation.
Furthermore, it should be examined whether the BRAF-V600 mutation detected on ctDNA from the pleural effusion is suitable as an indicator mutation for the diagnosis of pleural carcinosis and can serve as a companion diagnostic for the use of a combined BRAF / MEK inhibitor therapy.

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Organizational Data

  •   DRKS00017491
  •   2019/06/19
  •   [---]*
  •   yes
  •   Approved
  •   19017, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   C43 -  Malignant melanoma of skin
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C18 -  Malignant neoplasm of colon
  •   J90 -  Pleural effusion, not elsewhere classified
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Interventions/Observational Groups

  •   As part of the study, the therapeutically extracted pleural effusion will be examined once by using the fully automatic diagnostic system Idylla ™ from BIOCARTIS.
    The aim is to examine whether the gene mutation BRAF-V600 is detectable in the pleural puncture, even if no malignant cancer cells could be found. Since the cancer gene has already been detected with the NGS procedure on primary tumor or a metastasis, a direct comparison of both methods (NGS procedure and BIOCARTIS procedure) should be carried out in order to obtain a possible temporal benefit over the current investigations on the primary tumor or the metastasis.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Investigation of the possibility to increase the sensitivity of diagnoses of malignant pleural effusion compared to conventional pleural cytology by using the Idylla ™ ctBRAF mutation assay

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Secondary Outcome

Investigation of whether the method is also suitable as a companion diagnostic for the detection of a BRAF-V600 mutation in the area of ​​pleural carcinosis without the need for cell preparation on the pleural effusion;
Determination of the temporal benefit of the method compared to the standard procedure using Next Generation Sequencing

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2019/06/24
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Reliable diagnosis of malignant melanoma, mCRC or NSCLC;

Need for a regular therapy-related pleural puncture;

BRAF-V600 mutation already detected by NGS procedure in the primary tumor;

Signed informed consent form

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Exclusion Criteria

Absence of the written consent of the patient

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Onkologiezentrum Donauwörth
    • Mr.  Prof. (SHB) Dr. med.  Dirk  Hempel 
    • Neudegger Allee 10
    • 86609  Donauwörth
    • Germany
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    • Onkologiezentrum Donauwörth
    • Mr.  Prof. (SHB) Dr. med.  Dirk  Hempel 
    • Neudegger Allee 10
    • 86609  Donauwörth
    • Germany
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    • Onkologiezentrum Donauwörth
    • Mr.  MSc.  Karsten  Ziegler 
    • Neudegger Allee 10
    • 86609  Donauwörth
    • Germany
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Sources of Monetary or Material Support

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    • Onkologiezentrum Donauwörth
    • Mr.  Prof. (SHB) Dr. med.  Dirk  Hempel 
    • Neudegger Allee 10
    • 86609  Donauwörth
    • 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.