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@ARTICLE{SchrotzKing:157413,
      author       = {P. Schrotz-King$^*$ and M. Hoffmeister$^*$ and P. Sauer and
                      A. Schaible and H. Brenner$^*$},
      title        = {{E}ffects of {A}lternative {O}ffers of {S}creening
                      {S}igmoidoscopy and {C}olonoscopy on {U}tilization and
                      {Y}ield of {E}ndoscopic {S}creening for {C}olorectal
                      {N}eoplasms: {P}rotocol of the {DARIO} {R}andomized
                      {T}rial.},
      journal      = {JMIR Research Protocols},
      volume       = {9},
      number       = {8},
      issn         = {1929-0748},
      address      = {Toronto},
      reportid     = {DKFZ-2020-01608},
      pages        = {e17516},
      year         = {2020},
      note         = {#EA:C120#LA:C070#},
      abstract     = {Flexible sigmoidoscopy and colonoscopy are recommended
                      screening options for colorectal cancer (CRC). Despite
                      colonoscopy being offered for CRC screening in Germany, the
                      uptake of this offer has been very limited.The objective of
                      this study was to assess the potential for increasing use of
                      endoscopic CRC screening and the detection of advanced
                      colorectal neoplasms by offering the choice between use of
                      flexible sigmoidoscopy and colonoscopy.The DARIO study
                      includes a cross-sectional study (part I), followed by a
                      prospective 2-arm randomized controlled intervention trial
                      (part II) with an associated biobank study (part III).
                      Participation is possible in part I of the DARIO study only,
                      parts I and II, or all 3 study parts. After obtaining
                      informed consent from the municipalities, 12,000 people,
                      aged 50-54 years, from the Rhine-Neckar region in Germany
                      were randomly selected from residential lists of the
                      responsible population registries and invited to complete a
                      standardized questionnaire to investigate the nature,
                      frequency, timing, and results of previous CRC screening and
                      eventual diagnostic colonoscopies. In study part II
                      participants from study part I with no colonoscopy in the
                      preceding 5 years are randomized into 2 arms: arm A offering
                      screening colonoscopy only, and arm B offering both options,
                      either screening colonoscopy or screening sigmoidoscopy. The
                      primary endpoint is the proportion of participants in whom
                      colorectal neoplasms >0.5 cm are detected and removed at
                      screening endoscopy. The secondary endpoints are the
                      detection rate of any neoplasm and use of any endoscopic
                      screening. Part III of the study will use samples from
                      participants in study part II to construct a liquid and
                      tissue biobank for the evaluation of less invasive methods
                      of early detection of colon cancer and for the more detailed
                      characterization of the detected neoplasms. Blood, urine,
                      stool, and saliva samples are taken before the endoscopy.
                      Tissue samples are obtained from the neoplasms removed
                      during endoscopy.A total of 10,568 from 12,000 randomly
                      selected women and men aged 50-54 years living in the
                      Rhine-Neckar-Region of Germany have been invited for
                      participation. The remaining 1432 $(11.93\%)$ could not be
                      invited because they reached the age of 55 at the time of
                      contact. Of those invited, 2785/10,568 $(26.35\%)$
                      participated in study part I; $53.60\%$ (1493/2785) of these
                      participants were female. Study parts II and III are
                      ongoing.This study will answer the question if alternative
                      offers of either screening sigmoidoscopy or screening
                      colonoscopy will increase utilization and effectiveness of
                      endoscopic CRC screening compared with an exclusive offer of
                      screening colonoscopy. In addition, alternative noninvasive
                      screening tests will be developed and validated.German
                      Clinical Trials Register DRKS00018932;
                      $https://www.drks.de/drks_web/navigate.do?$
                      $navigationId=trial.HTML\&TRIAL_ID=DRKS00018932.DERR1-10.2196/17516.$},
      cin          = {C120 / C070},
      ddc          = {610},
      cid          = {I:(DE-He78)C120-20160331 / I:(DE-He78)C070-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32755890},
      doi          = {10.2196/17516},
      url          = {https://inrepo02.dkfz.de/record/157413},
}