Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States and Europe. Although selected patients with oligometastatic CRC undergo systemic therapy and surgery/local ablative therapy in curative intent, the treatment approach for the majority of metastatic CRC (mCRC) patients remains palliative with a median overall survival (OS) ranging between 9-38 months depending on various prognostic and predictive factors. Particularly in advanced stages (in the third line of therapy and beyond), interesting and promising results have recently been achieved with various treatment approaches. The aim of this registry is to establish a disease-specific registry to evaluate the treatment landscape of patients with mCRC who have already received at least two lines of therapy.
This registry aims at retrospectively and prospectively evaluating the treatment landscape and clinical outcome of mCRC ≥3L in a collective attempt by including multiple oncologic centers in Austria. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. Imaging studies ≥3L will be centrally collected in a virtual "imaging-bank" and tumor tissue samples of deceased patients will be stored in a central "bio-bank". Additionally, further biomaterial (e.g. ctDNA samples or DNA from DPYD genotyping) may be requested from the centres in case of specific research questions. The patient follow-up data will be obtained until patient death or loss to follow-up. For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which have already been recorded in the patients' medical charts, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patients' medical and other registry information throughout the lifetime of the registry. A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients. Data will be collected from all sites willing to participate.
Study Type
OBSERVATIONAL
Enrollment
500
Ordensklinikum Linz, BHS - Interne I
Linz, Austria
RECRUITINGKUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie
Linz, Austria
RECRUITINGLKH Feldkirch: Innere Medizin II/ Interne E (Hämatologie und Onkologie)
Rankweil, Austria
RECRUITINGDepartment of Internal Medicine III, Paracelsus Medical University Salzburg
Salzburg, Austria
RECRUITINGKlinikum Steyr: Innere Medizin II: Onkologie, Gastroenterologie, Angiologie
Steyr, Austria
RECRUITINGKlinikum Wels: Abteilung für Innere Medizin IV
Wels, Austria
RECRUITINGKH Zams: Innere Medizin Internistische Onkologie und Hämatologie
Zams, Austria
RECRUITINGOverall Survival
Overall survival with the respective treatment protocols ≥3L
Time frame: 10 years
Progression free survival
Progression-free survival (PFS) with the respective treatments protocols ≥3L
Time frame: 10 years
Overall response rate (ORR)
Overall response rate (ORR) with the respective ≥3L treatment protocols
Time frame: 10 years
Blinded Independent Central Review (BICR)
Blinded Independent Central Review (BICR) based on the virtual imaging-bank
Time frame: 10 years
Identification of predictive biomarkers
Identification of predictive biomarkers for mCRC patient sub-cohorts of interest based on the centrally-located bio-bank
Time frame: 10 years
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