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    Summary
    EudraCT Number:2019-003770-85
    Sponsor's Protocol Code Number:DKFZ-2019-007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-06-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-003770-85
    A.3Full title of the trial
    Effect of low-dose acetylsalicylic acid on early detection of advanced colorectal neoplasms
    Mit ASS Darmtumore früher erkennen 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detect colon cancer earlier with ASA 2
    Mit ASS Darmtumore früher erkennen 2
    A.3.2Name or abbreviated title of the trial where available
    ASTER 2
    ASTER 2
    A.4.1Sponsor's protocol code numberDKFZ-2019-007
    A.5.4Other Identifiers
    Name:Deutsches Register Klinischer Studien (DRKS)Number:DRKS00020940
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGerman Cancer Research Center (DKFZ)
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDeutsche Krebshilfe (German Cancer Aid)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportGerman Cancer Research Center (DKFZ)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMAST Diagnostica GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGerman Cancer Research Center (DFKZ)
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 280
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.6E-mailcto@dkfz-heidelberg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ASS-ratiopharm® 100 mg TAH Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Screening for advanced colorectal neoplasms.

    Male individuals aged 40 to 79 years scheduled for screening colonscopy and no use of acetylsalicylic acid (or other drugs with an effect on the blood coagulation system).
    Screening auf fortgeschrittene kolorektale Neoplasien.

    Männliche Personen im Alter von 40 bis 79 Jahren, bei denen eine Screening-Koloskopie geplant ist und die keine Acetylsalicylsäure (oder anderen Medikamenten mit Auswirkungen auf das Blutgerinnungssystem) einnehmen.
    E.1.1.1Medical condition in easily understood language
    Screening for colon cancer.

    Male individuals aged 40 to 79 years scheduled for screening colonscopy and no use of blood thinning medicines.
    Darmkrebs-Vorsorge.
    Männliche Personen im Alter von 40 bis 79 Jahren, bei denen eine Darmspiegelung geplant ist und die keine blutverdünnenden Medikamente einnehmen.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Effect of three days of repeated intake of 100 mg acetylsalicylic acid (ASA, cumulative dose of 3 x 100 mg) on sensitivity for early detection of advanced colorectal neoplasm (defined as CRC, advanced adenoma or sessile serrated polyp/adenoma ≥ 1 cm), measured via a fecal immunochemical test (OC-Sensor) at the predefined cutoff level of 10.0 µg hemoglobin/g feces.
    E.2.2Secondary objectives of the trial
    - Effect of repeated intake 100 mg ASA on sensitivity for detection of advanced colorectal neoplasm after different durations of intake and cumulative doses of ASA (200 mg, 300 mg, 400 mg, respectively).
    - Effect of repeated intake of 100 mg ASA on specificity and positivity rate after different durations and cumulative doses of ASA.
    - Frequency and clinical relevance of bleeding at screening colonoscopy in relation to the time since the last ASA intake.
    - Frequency and type of (serious) adverse events.

    Tertiary objective:
    - To collect additional blood and stool samples that will be used for further research outside of the study protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male
    • Age 40 to 79 years
    • Planned screening colonoscopy
    • No history of colorectal cancer
    • No regular use of any drug with an effect on the blood clotting/coagulation system
    • Able to speak and understand German sufficiently to be able to give written informed consent and comply with the study requirements
    E.4Principal exclusion criteria
    • No screening colonoscopy (e.g. diagnostic or surveillance colonoscopy)
    • Colonoscopy due to visible blood in stool
    • Colonoscopy due to positive fecal occult blood test
    • History of colorectal cancer
    • History of severe gastrointestinal bleeding
    • Chronic inflammatory bowel disease (e.g. Crohn’s disease, colitis ulcerosa)
    • Contraindication to the trial medication
    • Special warnings and precautions for use to the trial medication
    • Recent use of any drug with an effect on the blood clotting/coagulation system
    • Intention to use any drug that interacts with the trial medication durign the clinical study phase
    • Planned surgery/dental treatment during the study
    • Participation in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Effect of three days of repeated intake of 100 mg ASA (cumulative dose of 3 x 100 mg) on sensitivity for early detection of advanced colorectal neoplasm (defined as CRC, advanced adenoma or sessile serrated polyp/adenoma ≥ 1 cm), measured via a fecal immunochemical test (OC-Sensor) at the predefined cutoff level of 10.0 µg hemoglobin/g feces.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the evaluation of the primary endpoint, the collection of two stool samples (one sample before the ASA intake and one sample 3 days after the start of ASA intake (day 4, cumulative dose of 3 x 100 mg ASA; first choice) are sufficient. The collection of the baseline stool sample should not be a problem; however, the collection of the stool sample exactly three days after the start of ASA intake (day 4) might not be feasible for every study participant. If the stool sample on day 4 is missing, the stool sample of day 5 (after a cumulative intake of 400 mg ASA; second choice) or the stool sample of day 3 (after a cumulative intake of 200 mg ASA; third choice) will be used for calculation.
    E.5.2Secondary end point(s)
    1) Effect of repeated intake 100 mg ASA on sensitivity for detection of advanced colorectal neoplasm after different durations of intake and cumulative doses of ASA (200 mg, 300 mg, 400 mg, respectively).
    2) Effect of repeated intake of 100 mg ASA on specificity and positivity rate after different durations and cumulative doses of ASA.
    3) Frequency and clinical relevance of bleeding at screening colonoscopy in relation to the time since the last ASA intake.
    4) Frequency and type of (serious) adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2) After day 3, day 4 and day 5, respectively.
    3) After screening colonoscopy.
    4) After day 5.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Day 6, which is the first day after the last fecal sample collection will be defined as end of the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 811
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 414
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1225
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No further treatment with the trial medication is needed after the end of the intervention. The study intervention is only necessary before the fecal sample collection. Afterwards for all study participants a screening colonscopy (gold standard) is planned.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2025-01-13
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