se of Acetylsalicylic Acid (ASA) for Enhanced Early Detection of Colorectal Neoplasms

Phase 3

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

• Registration Number: DRKS00003252
• Lead Sponsor: Deutsches Krebsforschungszentrum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-13
• Study Completion: 2017-01-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2422

Inclusion Criteria

• Age 40 to 80 years (both males and females; premenopausal women must have a negative pregnancy test before inclusion into the study, postmenopausal women are women who have not had menstrual bleeding for at least 12 months, or have been surgically sterilized)
• Planned screening or diagnostic colonoscopy
• Able to speak and understand German sufficiently to be able to give written informed consent and comply with the study requirements

Exclusion Criteria

1. Factors potentially influencing the primary endpoint
a. Diseases/symptoms
a1. Chronic inflammatory bowel disease
a2. Angiodysplasia of the colon
a3. Anamnestic or observed blood loss per anum
b. Use of any of the following drugs
b1. Within 2 weeks before the study
• Anticoagulants (including, but not limited to heparin, vitamin K antagonists, e.g. phenprocoumon, warfarin, direct thrombin inhibitors)
• Antiplatelet drugs (e.g. clopidogrel, prasugrel, ticlopidin)
b2. Within 1 week before the study
• Acetylsalicylic acid
b3. Within 3 days before the study
• NSAIDs and COX-2 inhibitors

2. Factors potentially affecting the safety
a. Any current clinically relevant signs and symptoms, including
a1. Signs and symptoms suggesting acute gastrointestinal ulcer
a2. Known clinically relevant thrombocytopenia
a3. Acute infection
a4. Volume deficit (exsiccosis)
a5. Any currently present allergy with dermal reactions, pruritus, or urticaria
a6. Severe or insufficiently controlled asthma
a7. Severe kidney or liver diseases
a8. Any liver cirrhosis
a9. Severe, not sufficiently treated heart failure
a10. Severe, poorly controlled hypertension
a11. Any other unclear symptoms needing further investigation in the opinion of the investigator
b. Any of the following anamnestic findings
b1. History of severe gastrointestinal bleeding
b2. Known hemorrhagic diathesis, including, but not limited to, hypoprothrombinaemia, thrombocytopenia, hemophilia
b3. Asthma, except for patients who have used acetylsalicylsäure in the past without negative effects
b4. Hypersensitivity against salicylic acid or other ingredients of the study drugs
b5. Previous intolerance to NSAIDs, COX-2 inhibitors, or antirheumatic medication
b6. Severe gout (e.g. recurrent attacks)
b7. Hereditary oxaluria
b8. Known G6PD or glutathione peroxidase deficiency
b9. Known epilepsy with generalised seizures
b10. Severe cardiac diseases (including, but not limited to, myocardial infarction in the past 6 months)
c. Intention to use any of the following drugs during the study
c1. Anticoagulants
c2. Antiplatelet drugs
c3. NSAIDs, COX-2 inhibitors
c4. Methotrexate = 15 mg/week
c5. Systemic glucocorticoids
c6. Selective serotonin reuptake inhibitors (SSRIs)
c7. Valproic acid
d. Planned surgery/dental treatment during participation in the study
e. Known pregnancy or lactation

3. Other factors
a. Known or suspected relevant alcohol abuse
b. Known or suspected illicit drug abuse
c. Suspected non-compliance with the study procedures
d. Participation in another clinical study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate diagnostic performance (sensitivity, specificity, positive and negative predictive values, likelihood ratios, area under the curve) of 2 imunochemical Fecal Occult Blood Tests for detecting advanced colorectal neoplasms after a single dose of aspirin as compared to application of the tests without prior use of aspirin.