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J. Sahlmann

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    Poster Display Session (ID 63)

    • Event: ELCC 2017
    • Type: Poster Display Session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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      125P - Clinical research platform into molecular testing, treatment and outcome of non-small cell lung carcinoma Patients (CRISP): A prospective German registry in stage IV NSCLC, AIO-TRK-0315 (ID 388)

      12:30 - 13:00  |  Author(s): J. Sahlmann

      • Abstract

      Treatment in NSCL is quickly evolving and new agents make it to the routine practice at a rapid pace. Whether outcome and PRO data generated in clinical trials with often narrow inclusion and exclusion criteria will hold up in the routine practice is of high interest, especially due to the increasing costs of new drugs. Therefore, registry data are of ever increasing importance to patients, physicians and reimbursement institutions.

      Therefore, we have started a prospective, clinical registry for patients with metastatic NSCLC. The purpose of CRISP is to set up a national clinical research platform to document representative data on molecular testing, sequences of systemic therapies and other treatment modalities, course of disease in patients with advanced or metastatic NSCLC in Germany not amenable to curative treatment. A particular focus is on molecular biomarker testing of patients before the start of 1[st] -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 decentral tissue annotation for future collaborative, investigational scientific biomarker testing. This study will be carried out in up to 150 representative cancer centers in all therapeutic sectors in Germany. More than 8000 patients will be recruited and followed up to a maximum of 3 years, respectively until death.

      The first patients have been included in Dec. 2015. As of Jan. 2[nd] 2017, 71 centers are recruiting patients and 529 patients have been recruited. Preliminary data will be presented at the meeting for molecular testing, demographic data as well as treatment stratification in the 1[st] line setting.

      The registry CRISP will be the first to present representative real life data, covering all treatment settings of patients with NSCLC in Germany.

      Clinical trial identification:

      Legal entity responsible for the study:

      CRISP is supported by Grants from AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, Lilly Deutschland GmbH, MSD Sharp & Dohme GmbH, Novartis Pharma GmbH, and Pfizer Pharma GmbH.

      All authors have declared no conflicts of interest.