Detect colon cancer earlier with ASA 2

Effect of low-dose acetylsalicylic acid on early detection of advanced colorectal neoplasms - ASTER 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003770-85-DE

Enrollment

1225

Registered

2020-06-29

Start date

2020-08-20

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

Trade Name: ASS-ratiopharm® 100 mg TAH Tabletten Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

Male

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 811 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 414

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: - 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 ;Primary 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. ;Timepoint(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 (afte	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: - 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 ;Primary 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. ;Timepoint(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 (afte

—

Secondary

Measure	Time frame
Secondary 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. ;Timepoint(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.	—

Measure

Time frame

Secondary 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. ;Timepoint(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.

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Countries

Germany

Contacts

Public ContactClinical Trial Office

German Cancer Research Center (DFKZ)

cto@dkfz-heidelberg.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026