Early detection of Colorectal neoplasms MedDRA version: 19.0 Level: HLT Classification code 10010023 Term: Colorectal neoplasms malignant System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ASS-ratiopharm
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Other descriptive name: ACETYLSALICYLIC ACID
Concentration unit: mg milligram(s)
Co
Sponsors
German Cancer Research Center (DKFZ)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 2400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2400
Exclusion criteria
Exclusion criteria: Factors potentially influencing the primary endpoint Diseases/symptoms: -Chronic inflammatory bowel disease (e.g. Crohn’s disease, colitis ulcerosa) -Colonoscopy due to positive fecal occult blood test -History of Colorectal cancer -Angiodysplasia of the colon -Anamnestic or observed blood loss per anum Use of any of the following drugs 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 [apixapan, rivaroxaban]) -Antiplatelet drugs (e.g. clopidogrel, prasugrel, ticlopidin) Within 1 week before the study -Acetylsalicylic acid Within 3 days before the study -NSAIDs and COX-2 inhibitors -Factors potentially affecting the safety -Any current clinically relevant signs and symptoms, including -Signs and symptoms suggesting acute gastrointestinal ulcer -Known clinically relevant thrombocytopenia .Acute infection -Volume deficit (exsiccosis) -Any currently present allergy with dermal reactions, pruritus, or urticaria -Severe or insufficiently controlled asthma -Severe kidney or liver diseases (e.g. GFR <30 ml/min, liver cirrhosis) -Severe, not sufficiently treated heart failure (as judged by the investigator) -Severe, poorly controlled arterial hypertension -Any other unclear symptoms needing further investigation in the opinion of the investigator Any of the following anamnestic findings -History of severe gastrointestinal bleeding -Known hemorrhagic diathesis, including, but not limited to, hypoprothrombinaemia, severe thrombocytopenia, hemophilia -Asthma, except for patients who have used acetylsalicylic acid in the past without negative effects -Hypersensitivity against salicylic acid or other ingredients of the study drugs -Previous intolerance to NSAIDs, COX-2 inhibitors, or antirheumatic medication -Severe gout (e.g. recurrent attacks) -Hereditary oxaluria -Known G6PD or glutathione peroxidase deficiency -Known epilepsy with generalised seizures -Severe cardiac diseases (including, but not limited to, myocardial infarction in the past 6 months) Intention to use any of the following drugs during the study: -Anticoagulants -Antiplatelet drugs -NSAIDs, COX-2 inhibitors -Methotrexate = 15 mg/week -Systemic glucocorticoids -Selective serotonin reuptake inhibitors (SSRIs) -valproic acid Planned surgery/dental treatment during participation in the study Other factors Known or suspected relevant alcohol abuse Known or suspected illicit drug abuse Pregnancy Suspected non-compliance with the study procedures Participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate diagnostic performance (sensitivity, specificity, positive and negative predictive values, likelihood ratios, area under the curve) of 2 immunochemical Fecal Occult Blood Tests (iFOBTs) for detecting advanced colorectal neoplasms after a single dose of acetylsalicylic acid as compared to placebo;Secondary Objective: To study gender-specific performance of the 2 iFOBTs and the possible gain in diagnostic performance by stool sampling on multiple days. To study the safety of single-dose acetylsalicylic acid in the selected population. To collect blood samples for additional biomarker analyses (optional) ;Primary end point(s): Sensitivity at predefined cutpoints of test positivity of the RIDASCREEN® test to detect advanced neoplasms. ;Timepoint(s) of evaluation of this end point: on day 3,4,5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • positive and negative predictive values • specificity and the area under the curve in ROC analyses • likelihood ratios • gender-specific performance of the tests • gain in diagnostic performance by test application on multiple days • serious adverse events ;Timepoint(s) of evaluation of this end point: on day 3,4,5 | — |
Countries
Germany
Contacts
Public ContactGerman Cancer Research Center
German Cancer Research Center
Outcome results
None listed