Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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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 metastatic 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 advanced or metastatic
NSCLC not amenable to curative treatment. A particular focus is on molecular biomarker
testing of patients before the start of first-line treatment. 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 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
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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

  •   Other: data collection
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

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

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   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

- Histologically confirmed non-small cell lung cancer (NSCLC)

- Stage IV or stage IIIB (UICC7) if patient is ineligible for curative surgery and/or
radiochemotherapy

- Informed consent no later than four weeks after start of (palliative) firstline
treatment

- Age ≥ 18 years

- Able to understand and willing to sign written Informed Consent and to complete
patient-reported-outcome assessment instruments

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Exclusion Criteria

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Addresses

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    • AIO-Studien-gGmbH
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    • AstraZeneca
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    • Celgene Corporation
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    • Merck Sharp & Dohme Corp.
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    • Novartis Pharmaceuticals
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    • Pfizer
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    • Boehringer Ingelheim
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    • Bristol-Myers Squibb
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    • iOMEDICO AG
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    • Pius-Hospital Oldenburg
    • Frank Griesinger, Prof. Dr. 
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    • Aysun Karatas, Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
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  •   2016/02/25
* This entry means the parameter is not applicable or has not been set.