early detection of colon cancer

Phase 1

• Conditions: Early detection of Colorectal neoplasms; MedDRA version: 19.0Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005603-32-DE
• Lead Sponsor: German Cancer Research Center (DKFZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-30
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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