Trial document




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  DRKS00018788

Trial Description

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Title

A monocenter registry study to document clinical, biological and quality of life parameters in patients with gastrointestinal tumors

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Trial Acronym

GASTRY

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Documentation of patient data of patients with gastrointestinal tumors or unknown primary including measurement of life quality.

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Brief Summary in Scientific Language

A monocenter registry for documenting clinical, biological and quality of life parameters in patients with gastrointestinal tumors.

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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

  •   DRKS00018788
  •   2020/01/14
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  •   yes
  •   Approved
  •   F-2019-066, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   Gastrointestinal tumors
  •   CUP-SYNDROM
  •   C15-C26 -  Malignant neoplasms of digestive organs
  •   C80 -  Malignant neoplasm, without specification of site
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Interventions/Observational Groups

  •   Documentation of clinical data including molecular diagnostic results and quality of life in patients with gastrointestinal tumors or unknown primary.
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Characteristics

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

Comparison of Overall Survival between patients who received a molecular-stratified therapy after first tumor progression at latest and patients who did not.

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Secondary Outcome

- Comparison of PFS with molecular-stratified therapy and preceding therapy (PFS-Ratio)
- Evaluation of efficacy of therapies with pre-defined parameters
- Evaluation of Tumor board decisions
- Development of a molecular map based on NGS analyses, sub-typing of molecular signalling pathways
- Correlation between mutational status and clinical parameters resp. quality of life
- Identification of prognostic and predictive factors

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/01/01
  •   100
  •   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

• Patients with advanced GI Tumor or CUP Syndrome and indication of systemic treatment
• Molecular examination indicated
• Age ≥18 Jahre
• Written informed consent

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Exclusion Criteria

• Severe neurologic or psychiatric disorders which interfere with the patient's ability to provide informed consent

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Addresses

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    • SLK-Kliniken Heilbronn GmbH
    • Am Gesundbrunnen 20-26
    • 74078  Heilbronn
    • Germany
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    • SLK-Kliniken Heilbronn GmbH
    • Ms.  Dr. rer.nat.  Dilyana  Vladimirova 
    • Am Gesundbrunnen 20-26
    • 74078  Heilbronn
    • Germany
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    • SLK-Kliniken Heilbronn GmbH
    • Mr.  Josef  Huber 
    • Am Gesundbrunnen 20-26
    • 74078  Heilbronn
    • Germany
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Sources of Monetary or Material Support

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    • SLK-Kliniken Heilbronn GmbH
    • Am Gesundbrunnen 20-26
    • 74078  Heilbronn
    • Germany
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    •   [---]*
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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.