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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

BMC Cancer 1/2018

Clinical 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

Zeitschrift:
BMC Cancer > Ausgabe 1/2018
Autoren:
Kaja Tikk, David Czock, Walter E. Haefeli, Annette Kopp-Schneider, Hermann Brenner
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s12885-018-4826-3) contains supplementary material, which is available to authorized users.
Kaja Tikk and David Czock share the first authorship.
Kaja Tikk and David Czock contributed equally to the preparation of the manuscript.

Abstract

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.

Methods/design

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.

Discussion

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.

Trial registration

This trial was registered before recruitment of the participants in www.​clinicaltrialsre​gister.​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.
Zusatzmaterial
Additional file 1: List of Ethics Committees who were involved in approval of the trial. (DOCX 20 kb)
12885_2018_4826_MOESM1_ESM.docx
Literatur
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