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@ARTICLE{Tikk:141396,
      author       = {K. Tikk$^*$ and D. Czock and W. E. Haefeli and A.
                      Kopp-Schneider$^*$ and H. Brenner$^*$},
      title        = {{C}linical trial protocol of the {ASTER} trial: a
                      double-blind, randomized, placebo-controlled phase {III}
                      trial evaluating the use of acetylsalicylic acid ({ASA}) for
                      enhanced early detection of colorectal neoplasms.},
      journal      = {BMC cancer},
      volume       = {18},
      number       = {1},
      issn         = {1471-2407},
      address      = {Heidelberg},
      publisher    = {Springer},
      reportid     = {DKFZ-2018-01902},
      pages        = {914},
      year         = {2018},
      abstract     = {ᅟ: Immunochemical fecal occult blood tests (iFOBTs) are
                      increasingly used for colorectal cancer (CRC) screening. In
                      our preceding observational study, sensitivity for detecting
                      advanced colorectal neoplasms by iFOBT was $70.8\%$ among
                      users of low-dose acetylsalicylic acid compared with
                      $35.9\%$ among non-users (p = 0.001), whereas there were
                      only very small differences in specificity. In receiver
                      operating characteristics (ROC) analyses, the area under the
                      curve (AUC) was much higher for acetylsalicylic acid users
                      than for non-users, with particularly strong differences in
                      men (0.87 versus 0.68, p = 0.003). These findings
                      suggested that use of acetylsalicylic acid before conduct of
                      iFOBT might be a promising approach to improve non-invasive
                      screening for CRC.In this randomized, double-blind,
                      placebo-controlled trial, the diagnostic performance of two
                      iFOBTs for detecting advanced colorectal neoplasms after a
                      single low-dose of acetylsalicylic acid (300 mg) compared
                      to placebo is evaluated. Acetylsalicylic acid or placebo is
                      administered at least 5 days before a planned,
                      study-independent colonoscopic screening in 2400
                      participants aged 40 to 80 years. Stool samples are
                      obtained before and on three different days after the single
                      dose of acetylsalicylic acid or placebo. In addition,
                      optional blood samples are taken for future biomarker
                      analyses. The diagnostic performance of the iFOBTs will be
                      compared to the results of the colonoscopy as a gold
                      standard for the diagnosis of colorectal neoplasms.
                      Additionally, gender-specific performance of the tests and
                      gain in diagnostic performance by test application on
                      multiple days will be evaluated.If the findings from our
                      preceding observational study will be confirmed in this
                      large trial, the proposed low-risk, inexpensive intervention
                      would considerably improve the diagnostic accuracy of iFOBTs
                      and thus lead to enhanced early detection of colorectal
                      neoplasms. Thus, the results of this trial may have a large
                      public health impact.This trial was registered before
                      recruitment of the participants in
                      www.clinicaltrialsregister.eu on the 30th of May 2012:
                      EudraCT No.: 2011-005603-32 and in www.drks.de on 13th of
                      March 2012: German Clinical Trials Register DRKS-ID:
                      DRKS00003252 .},
      cin          = {C070 / L101 / C060 / G110},
      ddc          = {610},
      cid          = {I:(DE-He78)C070-20160331 / I:(DE-He78)L101-20160331 /
                      I:(DE-He78)C060-20160331 / I:(DE-He78)G110-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:30249195},
      pmc          = {pmc:PMC6154882},
      doi          = {10.1186/s12885-018-4826-3},
      url          = {https://inrepo02.dkfz.de/record/141396},
}