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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

Tikk, Kaja ; Czock, David ; Haefeli, Walter E. ; Kopp-Schneider, Annette ; Brenner, Hermann

In: BMC Cancer, 18 (2018), Nr. 914. pp. 1-9. ISSN 1471-2407

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Download (765kB) | Lizenz: Creative Commons LizenzvertragClinical 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 by Tikk, Kaja ; Czock, David ; Haefeli, Walter E. ; Kopp-Schneider, Annette ; Brenner, Hermann underlies the terms of Creative Commons Attribution 3.0 Germany

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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.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 .

Item Type: Article
Journal or Publication Title: BMC Cancer
Volume: 18
Number: 914
Publisher: BioMed Central ; Springer
Place of Publication: London ; Heidelberg ; Berlin
Date Deposited: 15 Oct 2018 09:46
Date: 2018
ISSN: 1471-2407
Page Range: pp. 1-9
Faculties / Institutes: Medizinische Fakultät Heidelberg > Pharmakologisches Institut
Service facilities > German Cancer Research Center (DKFZ)
Subjects: 610 Medical sciences Medicine
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