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    Clinical Trial Results:
    Use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

    Summary
    EudraCT number
    		 2011-005603-32
    Trial protocol
    		 DE  
    Global end of trial date
    27 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jan 2023
    First version publication date
    27 Jan 2023
    Other versions
    Summary report(s)
    		 Trial results

    Trial information

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    Trial identification
    Sponsor protocol code
    K357
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    German Cancer Research Center (DKFZ)
    Sponsor organisation address
    Im Neuenheimer Feld 280, Heidelberg, Germany, 69120
    Public contact
    German Cancer Research Center, German Cancer Research Center, +49 6221421349, k.tikk@dkfz.de
    Scientific contact
    German Cancer Research Center, German Cancer Research Center, +49 6221421349, k.tikk@dkfz.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate diagnostic performance (sensitivity, specificity, positive and negative predictive values, likelihood ratios, area under the curve) of 2 immunochemical Fecal Occult Blood Tests (iFOBTs) for detecting advanced colorectal neoplasms after a single dose of acetylsalicylic acid as compared to placebo
    Protection of trial subjects
    Candidate-participants in the study will be excluded if they use potentially interacting medication or have illnesses that may be worsened by participation in this study (for details, see exclusion criteria). In the study information documents, participants will be informed about all relevant potential adverse effects. Before being asked to participate in the study, the participants have all decided to undergo colonoscopy as a screening or diagnostic procedure. The time between drug intake and the planned colonoscopy allows for recovery of haemostatic functions (see below). Thus, the colonoscopy is not considered to be a part of the study. In case of an emergency situation, in which a treating physician feels that information on whether the participant received acetylsalicylic acid or placebo is needed for adequate medical treatment of the participant, it is possible to unblind the randomization information
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 2422
    Worldwide total number of subjects
    2422
    EEA total number of subjects
    2422
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1788
    From 65 to 84 years
    634
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Men and women aged 40 to 80 years with no recent use of aspirin or ther drugs with antithrombotic effects were recruited when visiting 1 of 18 trial centers in Germany for a pre-colonoscopy appointment.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Age 40 to 80 years (both males and females), planned screening or diagnostic colonoscopy, no antithrombotic drug intake, able to speak and understand German sufficiently to give informed consent

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 participants receiving trial medication
    Arm type
    		 Experimental

    Investigational medicinal product name
    Acetylsalicylic acid
    Investigational medicinal product code
    Other name
    ASS; ASA; aspirin
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ASS-ratiopharm, 300 mg, single oral dose of administration

    Arm title
    		 Placebo
    Arm description
    		 Participants receiving Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral dose

    Number of subjects in period 1
    		Verum Placebo
    Started
    1208
    1214
    Completed
    1075
    1059
    Not completed
    133
    155
         Physician decision
    20
    35
         Drop-out
    77
    61
         no stool samples
    32
    56
         Protocol deviation
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 participants receiving trial medication

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receiving Placebo

    Reporting group values
    		 Verum Placebo Total
    Number of subjects
    		 1208 1214 2422
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 801 780 1581
        From 65-84 years
    		 274 279 553
        85 years and over
    		 0 0 0
        DropOut
    		 133 155 288
    Gender categorical
    Units: Subjects
        Female
    		 528 531 1059
        Male
    		 547 528 1075
        Drop-Out
    		 133 155 288
    Subject analysis sets

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    final analysis per protocol

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    subjects in safety follow up after medication

    Subject analysis sets values
    		 Per Protocol Safety
    Number of subjects
    2134
    2134
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    1581
    1581
        From 65-84 years
    553
    553
        85 years and over
    0
    0
        DropOut
    0
    0
    Age continuous
    Units:
        
    59,6 ± 40
    59,6 ± 40
    Gender categorical
    Units: Subjects
        Female
    1059
    1059
        Male
    1075
    1075
        Drop-Out
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 participants receiving trial medication

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receiving Placebo

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    final analysis per protocol

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    subjects in safety follow up after medication

    Primary: Sensitivity and Specificity of iFOBT 10 µg Hb

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    End point title
    		 Sensitivity and Specificity of iFOBT 10 µg Hb [1]
    End point description
    Sensitivity and Specificity of immunochemical FOBT (fecal occult blood test) at cutoff 10.2 µg Hemoglobin / g stool
    End point type
    Primary
    End point timeframe
    2 days after tablet intake
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statsistical analyses used in the trial were not compatible with the selectable parameters. Information on statistical analyses is provided in the attached Study Report.
    End point values
    		 Verum Placebo Per Protocol
    Number of subjects analysed
    1075
    1059
    2134
    Units: cutoff
        number (not applicable)
    40.2
    30.4
    9.8
    No statistical analyses for this end point

    Primary: Sensitivity and Specificity of iFOBT 17µg

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    End point title
    		 Sensitivity and Specificity of iFOBT 17µg [2]
    End point description
    Sensitivity and Specificity of immunochemical FOBT (fecal occult blood test) at cutoff 17 µg Hemoglobin / g stool
    End point type
    Primary
    End point timeframe
    2 days after tablet intake
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statsistical analyses used in the trial were not compatible with the selectable parameters. Information on statistical analyses is provided in the attached Study Report.
    End point values
    		 Verum Placebo Per Protocol
    Number of subjects analysed
    1075
    1059
    2134
    Units: cutoff
        number (not applicable)
    28.6
    22.5
    6.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 -

    Serious adverse events
    		 Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 2134 (0.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Appendicitis
         subjects affected / exposed
    1 / 2134 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 2134 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.01%
    Non-serious adverse events
    		 Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 2134 (0.14%)
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 2134 (0.05%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 2134 (0.05%)
         occurrences all number
    1
    Immune system disorders
    Rash
         subjects affected / exposed
    1 / 2134 (0.05%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 2134 (0.05%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2012
    - inclusion and exclusion criteria were changed with respect to pregnancy - study duration was updated - shipment of colonoscopy reports was specified - list of medication taken by the patient beforehand was specified - list of responsibilities of the investigators were deleted - check for completeness and plausibility of source documents was specified - the causality of an AE was changed from "unclassified" and "unclassifiable" to "not assessable" - reporting of SAEs by investigator was specified
    11 Mar 2013
    - Change of LKP - Responsibilities for data management and analysis were specified - terminology was specified - definition of drop-outs was specified
    01 Jul 2013
    Change of LKP within the same study center
    14 Aug 2015
    - Study duration prolonged - inclusion criteria changed - number of stool samples changed - observation period for AEs changed financial incentive for study centers was changed

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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