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

Phase 3

Recruiting

• Conditions: C18; C20; Malignant neoplasm of rectum; C19; Advanced colorectal neoplasia; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction

• Registration Number: DRKS00020940
• Lead Sponsor: Deutsches Krebsforschungszentrum (DKFZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 1225

Inclusion Criteria

• Males
• 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

Exclusion Criteria

• No screeening colonscopy (e.g. diagnostic or surveillance colonoscopy)
• Colonoscopy due to visible blood in stool
• Colonoscopy due to positive fecal occult blood test

• Diseases/symptoms or anamnestic finding:
o Chronic inflammatory bowel disease (e.g. Crohn’s disease, colitis ulcerosa)
o Angiodysplasia of the colon
o Signs or symptoms suggesting acute gastrointestinal ulcer
o Chronic constipation (less than 3 bowel movements per week)
o Anamnestic or observed blood loss per anum
o History of severe gastrointestinal bleeding
o Severe or insufficiently controlled asthma
o Asthma, except for patients who have used acetylsalicylic acid in the past without negative effects
o Acute infection
o Severe, not sufficiently treated heart failure
o Severe, poorly controlled arterial hypertension
o Severe cardiac diseases (including, but not limited to, myocardial infarction in the past 6 months)
o Known clinically relevant thrombocytopenia
o Known hemorrhagic diathesis, including, but not limited to, hypoprothrombinaemia, severe thrombocytopenia, hemophilia
o Known glucose 6 phosphate dehydrogenase (G6PD) deficiency
o Known glutathione peroxidase deficiency
o Volume deficit (exsiccosis)
o Severe kidney (e.g. GFR <30 ml/min)
o Severe liver disease (e.g. liver cirrhosis)
o Severe gout (e.g. recurrent attacks)
o Hereditary oxaluria
o Known epilepsy with generalized seizures
o Any currently present allergy with dermal reactions (e.g. urticaria) or pruritus
o Hypersensitivity against salicylic acid or other ingredients of the study drug (e.g. corn starch, microcrystalline cellulose, cellulose powder)
o Previous intolerance to NSAIDs, COX-2 inhibitors, or antirheumatic medication
o Any other unclear symptom needing further investigation in the opinion of the investigator

• Use of any drug with an effect on the blood clotting/coagulation system:
o Within 2 weeks before the study:
- Anticoagulants (including, but not limited to heparin, vitamin K antagonists [e.g. phenprocoumon, warfarin]), direct thrombin inhibitors (e.g. dabigatran), or factor Xa inhibitors (e.g. apixaban, rivaroxaban, edoxaban)
- P2Y12-Inhibitors (e.g. clopidogrel, prasugrel, ticagrelor)
o Within 1 week before the study:
- Acetylsalicylic acid (ASA)
o Within 3 days before the study
- NSAIDs (e.g. ibuprofen, diclofenac, naproxen) including COX-2 inhibitors (e.g. celecoxib, etoricoxib)

• Intention to use any of the following drugs during the study:
o Anticoagulants
o P2Y12-Inhibitors
o NSAIDs, including COX-2 inhibitors
o Methotrexate = 15 mg/week
o Systemic glucocorticoids
o Selective serotonin reuptake inhibitors
o Valproic acid
o Digoxin

• Planned surgery/dental treatment during the study
• Known or suspected alcohol abuse
• Known or suspected illicit drug abuse
• Suspected non-compliance with the study procedures
• Participation in another clinical trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of three days of repeat intake of 100 mg acetylsalicylic acid (cumulative dose of 3 x 100 mg) on sensitivity for early detection of advanced colorectal neoplasm (defined as colorectal cancer, advanced adenoma or sessile serrated polyp/adenoma in size = 1 cm), measured via a fecal immunochemical test (OC-Sensor) at the predefined cutoff level of 10.0 µg hemoglobin/g feces.

Secondary Outcome Measures

Name	Time	Method
- Effect of repeat intake of 100 mg acetylsalicylic acid (ASA) on sensitivity for detection of advanced colorectal neoplasm after different durations and cumulative doses of ASA (200 mg, 300 mg and 400 mg, respectively).<br>- Effect of repeat intake of 100 mg ASA on specificity and positivity rate after different durations and cumulative doses of ASA.<br>- Frequency and clinical relevance of bleeding at screening colonoscopy in relation to the time of the last ASA intake.<br>- Frequency and type of (serious) adverse events.