Trial document





This trial has been registered retrospectively.
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  DRKS00017456

Trial Description

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Title

Retrospective Determination of BRAF V600E Mutation in Papillary Thyroid Cancer

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Trial Acronym

BRAF-Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The BRAF V600E mutation is the most common genetic cause of papillary thyroid carcinoma. BRAF is a human gene encoding a protein called B-Raf. The gene is also known as protooncogene B-Raf and v-Raf mouse sarcoma virus oncogene homolog B, while the protein is formally known as serine / threonine protein kinase B-Raf. Some studies show that the detection of a BRAF V600E mutation as a characteristic of a more aggressive tumor is associated with a higher probability of recurrence and lymph node metastases, so that a more extensive surgical strategy should be pursued for preoperative mutation detection in fine needle puncture. However, the importance of this molecular diagnostics is still controversially discussed. The present study is designed as a retrospective study for the analysis of histological preparations of papillary thyroid carcinomas of the years 2007-2015. The aim is to investigate the extent to which the BRAF V600E mutation of papillary thyroid carcinomas was present in the own collective. In addition, it will be retrospectively evaluated whether the analysis of the BRAF V600E mutation status was performed preoperatively and to what extent the sonographic and scintigraphic malignancy criteria influenced the indication for surgery. Based on these results, a prospective randomized study with routine preoperative determination of the BRAF V600E mutation status in fine needle puncture, and depending on this a modification of the initial surgical strategy, is planned.

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Brief Summary in Scientific Language

Between 2007 and 2016, a total of 4039 thyroid surgeries were performed in the own collective, 410 of which were due to carcinoma. On average, 46 thyroid carcinomas were detected and operated on during this period. More than 75% of operated thyroid carcinomas are histologically papillary carcinomas. This corresponds to approximately 320 patients with a papillary thyroid carcinoma in the years 2007-2016.
We will contact all patients with papillary thyroid cancer from 2007 to 2016 with an information letter and a consent form. After consent has been given, the released pseudonymized samples will be retrospectively examined for the presence of a BRAF V600E mutation in cooperation with the Institute of Pathology of the Ruhr University Bochum. There, a microdissection and a sequence analysis of all preparations by means of polymerase chain reaction (PCR) will be performed. A laboratory visit of several weeks in Bochum by a doctoral student of the University Clinic for Visceral Surgery will be carried out as a basis for the exchange of knowledge and the intensification of cooperation.
The scientific staff will retrospectively investigate the extent to which a preoperative fine needle puncture and possibly already preoperative BRAF V600E mutation determination was performed, and the extent to which sonomorphological (echo-poor nodes with irregular margin limitation, microcalcifications and central hypervascularization) and scintigraphic (reduced or missing storage of a node) malignancy criteria were present in the positive cases. The database of the Competence Center for Thyroid and Parathyroid Surgery at the Pius-Hospital Oldenburg, which is maintained for quality assurance purposes, will be extended by the data collected in this study.

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Organizational Data

  •   DRKS00017456
  •   2019/06/12
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  •   yes
  •   Approved
  •   005/2017, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   C73 -  Malignant neoplasm of thyroid gland
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Interventions/Observational Groups

  •   All patients with papillary thyroid carcinoma from 2007 to 2016 will be contacted with an information letter and a consent form. After consent has been given, the released pseudonymized samples will be retrospectively examined for the presence of a BRAF V600E mutation in cooperation with the Institute of Pathology of the Ruhr University Bochum. A microdissection as well as a sequence analysis of all preparations by Polymerase Chain Reaction (PCR) will be performed. The scientific staff will retrospectively investigate the extent to which a preoperative fine needle puncture and possibly already preoperative BRAF V600E mutation determination was performed, and the extent to which sonomorphological (echo-poor nodes with irregular margin limitation, microcalcifications and central hypervascularization) and scintigraphic (reduced or missing storage of a node) malignancy criteria were present in the positive cases. The database of the Competence Center for Thyroid and Parathyroid Surgery at the Pius-Hospital Oldenburg, which is maintained for quality assurance purposes, will be extended by the data collected in this study.
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Characteristics

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

Examination of all preparations for the presence of a BRAF V600E mutation

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Secondary Outcome

- Analysis of the relationship between preoperative diagnostic procedures and the retrospectively determined presence of a BRAF V600E mutation
- Further development of the existing database of the Competence Centre for Thyroid and Parathyroid Surgery in the Pius Hospital Oldenburg
- Explorative analysis of the database

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/09
  •   320
  •   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

The resectates of all patients with papillary thyroid carcinoma who were taken from the Clinic for General and Visceral Surgery in the period 2007 to 2016 and for whom a declaration of consent is available are analyzed.

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Exclusion Criteria

All samples for which there is no declaration of informed consent from the patient will not be considered.

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Addresses

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    • Carl von Ossietzky Universität Oldenburg Fakultät VI - Medizin und Gesundheitswissenschaften
    • Ammerländer Heerstrasse 114-118
    • 26129  Oldenburg
    • Germany
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    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Mr.  Dr.  Navid  Tabriz 
    • Georgstrasse 12
    • 26121  Oldenburg
    • Germany
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    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Ms.  Dr.  Verena  Uslar 
    • Georgstrasse 12
    • 26122  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Carl von Ossietzky Universität Oldenburg Fakultät VI - Medizin und Gesundheitswissenschaften
    • Ammerländer Heerstrasse 114-118
    • 26129  Oldenburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/06/28
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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.