Trial document




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  DRKS00012890

Trial Description

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Title

Analysis of tumor DNA markers in the plasma of colorectal cancer patients by liquid biopsy

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Trial Acronym

Liquid Biopsy in colorectal cancer patients

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language


Each tumor has its own unique pattern of somatic mutations that can be used as prognostic factors and potential therapeutic targets. A number of these mutations are already tested in routine diagnostics, usually in tissue samples of the respective tumor. Lately, the analysis of plasma samples from cancer patients has been proposed for identifying tumor specific mutations. This is possible, as cell-free DNA of tumor cells (ctDNA) – as well as DNA from non-malignant cells – is present in the blood. However, the protocols used to date for ctDNA analysis have limitations. For example, there is no routine test at the moment to test for somatic copy number alterations (SCNAs) in ctDNA, a hallmark of colorectal cancer (CRC).
In this study, we will seek for hotspot mutations and genome-wide SCNAs in ctDNA of CRC patients, and monitor them over time. Therefore, we will first establish detection of ctDNA hotspot mutation analysis at the MGZ and develop a protocol for the genome-wide SCNA analysis from ctDNA using 50 patients with microsatellite stable (MSS) CRC. Subsequently, we will test whether ctDNA hotspot mutation and SCNA patterns can be used for the detection of therapy resistance as well as cancer relapse. Therefore, we will analyze consecutive blood samples from the same patients over time.
We will assess whether analysis of ctDNA would identify the same or even more tumor specific alterations as those obtained through invasive biopsy. We will further test, whether plasma ctDNA variant analysis and genome-wide SCNA analysis may be amenable to clinical routine applications in the future, aiming at predicting residual disease and treatment response, identifying therapy resistance mechanisms and new therapy approaches. As the aim of our study is the establishment and validation of a new laboratory method, individual results will not be communicated and therefore have no infuence on therapeutic decisions.

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Organizational Data

  •   DRKS00012890
  •   2017/09/14
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  •   yes
  •   Pending/not yet approved
  •   17059, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Plasma and EDTA samples (or buccal swabs) as well as paraffin embedded tumor tissue of patients with microsatellite stable colorectal cancer shall be analysed before therapy and over time to establish and validate hotspot mutation and somatic copy number variant (SCNAs) analysis. We therefore need the following samples:
    - Two Cell-Free DNA BCT CE Streck tubes with 8 ml blood per sampling for preparation of plasma-DNA.
    - Two BD Vacutainer CPT collection tubes with 8 ml blood per sampling for preparation of PBMC or two buccal swabs (only at study inclusion).
    - FFPE tissue samples from the primary tumor (from initial surgery)
  •   Plasma and EDTA samples (or buccal swabs) as well as paraffin embedded tumor tissue of tumor-free control persons shall be tested for hotspot mutations and somatic copy number variants (SCNAs) to identify technical artefacts and improve our protocols. We therefore need the following samples:
    - Two Cell-Free DNA BCT CE Streck tubes with 8 ml blood per sampling for preparation of plasma-DNA.
    - Two BD Vacutainer CPT collection tubes with 8 ml blood per sampling for preparation of PBMC or two buccal swabs
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Identification of tumorspecific SCNAs in plasma samples of colorectal cancer patients

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Secondary Outcome

Identification of tumorspecific hotspot mutations in plasma samples of colorectal cancer patients

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2017/09/15
  •   100
  •   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

Microsatellite stable colorectal cancer

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Exclusion Criteria

Neoadjuvant radio or chemotherapy has already started

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Addresses

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    • Medizinisch Genetisches Zentrum (MGZ)
    • Bayserstrasse 3-5
    • 80335  München
    • Germany
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    • Medizinisch Genetisches Zentrum (MGZ)
    • Ms.  Professor  Elke  Holinski-Feder 
    • Bayerstrasse 3-5
    • 80335  München
    • Germany
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    • Medizinisch Genetisches Zentrum (MGZ)
    • Ms.  Dr. med.  Verena  Steinke-Lange 
    • Bayserstrasse 3-5
    • 80335  München
    • Germany
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Sources of Monetary or Material Support

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    • Medizinisch Genetisches Zentrum (MGZ)
    • Bayerstrasse 3-5
    • 80335  München
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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