Detect colon cancer earlier with ASA 2

Phase 1

• 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).; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003770-85-DE
• Lead Sponsor: German Cancer Research Center (DKFZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-29
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 1225

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified