Colorectal cancer with a recent confirmed diagnosis (less than 48h) MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Adiro 100 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Ángel Lanas Arbeloa-Instituto de Investigación Sanitaria Aragón
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age from 18 to 80 years old - Recent diagnosis (less than 48h) of colorectal cancer by endoscopy and confirmed by anatomopathological study - normal hematologic, biochemical, and coagulation values 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Allergy to AAS or to any other NSAID. - Rectal cancer requiring neoadjuvant treatment wthin the two weeks following the beginning of ASA treatment. - Previous use of AAS, NSAIDs, antiplatelet agents, corticosteroids or misoprostol within the 15 days prior to diagnosis and/or anticipation of need for treatment with any of these drugs during the study period. History of peptic ulcer disease or active peptic ulcer or any other GI disease that may be considered a contraindication to the use of ASA, without the concomitant use of proton pump inhibitors. - Diagnosis of bleeding disorders. - Diagnosis of cancer (excluding non-melanoma skin cancer) during the previous 3 years. - Conditions supposing serious comorbidity, excluding diabetes, and including respiratory, cardiac, hepatic and renal diseases. - Active smoking. - Pregnancy or breastfeeding. - History of drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to perform a study of acetylsalicylic acid by using a proteomic assay for comparing platelet COX-1 and colorectal cancer mucosal COX-1 and COX-2 after different doses of acetylsalicylic acid;Secondary Objective: measurement of PGE2 and p-S6 levels in colorectal cancer mucosa, assessment of indirect biomarkers of acetylsalicylic acid action (serum TXB2, PFA and urinary levels of 11-dehydro-TXB2, (TX-M)), evaluation of systemic biomarkers of inflammatory/tumorigenic COX-2 by assessing urinary levels of major metabolite of PGE2 (PGE-M);Primary end point(s): Assessment of acetylation level of COX enzymes in platelets and non-neoplastic and neoplastic colonic tissues;Timepoint(s) of evaluation of this end point: before the beginning of the treatment and 3-4 weeks of acetylsalicylic acid treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): assessment of PGE2 level and S6 protein phosphorylation state in colorectal mucosa depending on AAS dosis and assessment of dosis effect e¡over indirect biomarkers;Timepoint(s) of evaluation of this end point: before the beginning of the treatment and 3-4 weeks of acetylsalicylic acid treatment | — |
Countries
Spain
Contacts
Public ContactUnidad de Investigación Clínica
Instituto de Investigación Sanitaria Aragón
Outcome results
None listed