Trial document




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  DRKS00010126

Trial Description

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Title

Clinical Research Platform Into Molecular Testing, Treatment and Outcome of Non-Small Cell Lung Carcinoma Patients

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Trial Acronym

CRISP

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URL of the Trial

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Brief Summary in Lay Language

Open, non-interventional, prospective, multi-center clinical research platform with the main
objective to assess molecular biomarker testing, treatment and outcome of patients with
advanced or metastatic NSCLC in Germany

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Brief Summary in Scientific Language

Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-life practice, is crucial to evaluate and improve the quality of care for patients with non-small cell lung cancer (NSCLC).
The purpose of CRISP is to set up a national clinical research platform to document uniform data on the molecular testing, treatment, course of disease in patients with NSCLC. A particular focus is on molecular biomarker testing before the start of first-line treatment of patients with advanced or metastatic NSCLC. The data shall be used to assess the current state of care and to develop recommendations concerning topics that could be improved.
PRO assessment will provide large-scale data on quality of life and anxiety/depression for real-life patients with NSCLC in routine practice. In addition, two questionnaires (concerning individual quality of life and patient-caregiver communication) will be validated in German patients with metastatic NSCLC.
Furthermore CRISP will set up a decentralized clinically annotated tissue repository for future collaborative, investigational scientific biomarker testing.

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Organizational Data

  •   DRKS00010126
  •   2016/07/06
  •   2015/12/02
  •   yes
  •   Approved
  •   F-2015-052#A1, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   NCT02622581  (ClinicalTrials.gov)
  •   AIO-TRK-0315  (AIO-Studien-gGmbH)
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Health Condition or Problem studied

  •   Metastatic Non-small Cell Lung Cancer (NSCLC)
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Patient with non-small cell lung cancer (NSCLC) documentation of real world date regarding treatment reality, molecular testing and quality of life
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Health care system
  •   Other
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Primary Outcome

To assess molecular biomarker testing, treatment and outcome of patients with NSCLC in Germany, in particular:

- To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment
- To describe types of surgeries, systemic treatments, radiochemotherapies, radiation therapies and sequential treatments thereof applied in real-life practice
- To assess effectiveness of treatments in regards to response rate, progression-free survival and overall survival
- To describe physician-reported factors affecting treatment decision making besides biomarker profiling
- To collect key data on specific supportive therapies
- To investigate changes in diagnostics, treatment or outcome during the course of the project
- To evaluate patient-reported outcomes concerning (1) general health-related and individual quality of life (QoL), (2) physical and psychological well-being, (3) anxiety and depression, (4) patient-caregiver communication

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2015/12/31
  •   5000
  •   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

1. Patients who meet all of the following criteria are eligible for the project:Histologically confirmed non-small cell lung cancer (NSCLC)
2. Informed consent no later than four weeks after start of first-line treatment
3. Age ≥ 18 years
4. Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments
5. Main project:
- Stage IV, IIIC or stage IIIB (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy
- Systemic therapy
In the main project it is strongly recommended that patients’ tumor samples are tested for EGFR mutation in exons 18-21, ALK rearrangement and ROS1 rearrangement as well as PD-L1 expression by a certified laboratory before the start of first-line treatment.
6. Satellite Stage II/III:
- Stage II, stage IIIA or stage IIIB (UICC8) if patient is eligible for curative surgery and/or radiochemotherapy
- systemic (chemo)therapy and/or radiation therapy and/or surgery

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Exclusion Criteria

none

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Addresses

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    • AIO-Studien-gGmbH
    • Ms.  Dr.  Aysun  Karatas 
    • Kuno-Fischer-Str. 8
    • 14057  Berlin
    • Germany
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    • Pius-Hospital Oldenburg
    • Mr.  Prof. Dr.  Frank  Griesinger 
    • Georgstr. 12
    • 26121  Oldenburg
    • Germany
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    • iOMEDICO AG
    • Ms.  Annette  Fleitz 
    • Ellen-Gottlieb-Straße 19
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • AstraZeneca GmbH
    • 22880  Wedel
    • Germany
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    • Boehringer Ingelheim Pharma GmbH & CO. KG
    • 55216  Ingelheim am Rhein
    • Germany
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    • Bristol-Myers Squibb GmbH & Co KGaA
    • 80636  München
    • Germany
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    • Celgene GmbH
    • 81829  München
    • Germany
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    • Lilly Deutschland
    • 61352  Bad Homburg
    • Germany
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    • MSD SHARP & DOHME GmbH
    • 85540  Haar
    • Germany
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    • Novartis Pharma GmbH
    • 90429  Nürnberg
    • Germany
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    • Pfizer Pharma GmbH
    • 10785  Berlin
    • Germany
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    • Roche Pharma AG
    • 79639  Grenzach-Wyhlen
    • Germany
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    • Takeda Pharma Vertrieb GmbH & Co.KG
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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