A Phase 3 interventional study of Acetylsalicylic acid and Screening colonoscopy in Colorectal Cancer, sponsored by Aragon Institute of Health Sciences. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2014-05-05.
Sponsored by Aragon Institute of Health Sciences · Phase 3, Interventional, and Prevention
In a preliminary study in healthy subjects, the investigators determined the pharmacokinetic and pharmacodynamic of enteric-coated acetylsalicylic acid (ASA) (Adiro 100 mg, Bayer), and the variability (coefficient of variation), accuracy and precision of a novel biomarker of ASA action, i.e., quantification of the extent of COX-1 acetylation at serine-529, using a stable isotope dilution liquid chromatography multiple reaction monitoring/mass spectrometry (LC-MS) technique.
Now, the investigators will perform a clinical study in individuals undergoing Colorectal cancer (CRC) to validate the hypothesis that that low-dose ASA given once daily is acting primarily by selectively acetylating platelet COX-1 and suppressing its activity throughout the 24-hour dosing interval. In contrast, it is expected that the inhibitory effect on extra-platelet sources of COX-1 will be short-lasting, if any, affecting only partially COX-1, and this effect will be completely reversed at 24 hours after dosing. This is an important point which will strengthen the platelet hypothesis underpinning the apparent adequacy of a 24-hour dosing interval of ASA administration for the anticancer effect detected in cardiovascular trials.
These patients will be stratified into individuals with adenomas/carcinomas (20 to 30%) and patients without clinically detected adenomas/carcinomas (about 70 to 80%).
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 40 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Aragon Institute of Health Sciences is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients should have an indication for screening colonoscopy
Exclusion Criteria:
Group 1, individuals will be treated with ASA for 1 week; then blood and tissue samples (during the screening colonoscopy) will be collected at from 6-7 h after the last dose of ASA.
Drug: Acetylsalicylic acid · Procedure: Screening colonoscopy
Group 2, individuals will be treated with ASA for 1 week; then blood and tissue samples (during the screening colonoscopy) will be collected at 24 hours after the last dose.
Drug: Acetylsalicylic acid · Procedure: Screening colonoscopy
One tablet of Adiro 100 mg will be administered daily for 7 days.
Also known as: Adiro 100, ASA
Assessment of the degree of COX-1 acetylation by ASA administered for 1 week.
It will be performed in platelets versus biopsies of the recto-colonic tissues.
Time frame: 7 hours after the 7th daily dose (group 1) and 24 hours after the 7th daily dose (group 2)
Changes from baseline in different biomarkers.
It will be used a combining technique of liquid chromatography with mass spectrometry (LC-MS/MS) to quantify the level of acetylation of COX-1 in circulating platelets in subjects treated with ASA. Parameters of the composite measure: * haemochrome, AST, ALT, gamma-GT, alkaline phosphatase (AP), total bilirubin, total protein, glucose, creatinine, N, Na, K, Ca. * urine analysis: pH, protein, albumin, glucose, RBC, bilirubin, nitrites, leucocytes and sediment.
Time frame: pre-drug on day 0 and after the 7th daily dose (6 hours for Group 1 and 24 hours for Group 2)
Changes from baseline in eicosanoid generation in vivo by measuring urinary metabolites derived from COXs.
It will be performed by ultra-performance liquid chromatography tandem mass spectrometry-mass spectrometry (UPLC/MS/MS).
Time frame: pre-drug on day 0 and after the 7th daily dose (6 hours for Group 1 and 24 hours for Group 2)
Changes in baseline platelet COX-1
By using human whole blood assay (serum TXB2) ex vivo
Time frame: pre-drug on day 0 and after the 7th daily dose (6 hours for Group 1 and 24 hours for Group 2)
Change from baseline in plasma proteins of markers of angiogenesis.
In blood sample by using an antibody array kit and Sphingosine-1 Phosphate (S1P) by immunoassay.
Time frame: pre-drug on day 0 and after the 7th daily dose (6 hours for Group 1 and 24 hours for Group 2)
Assessment of ASA plasma levels.
Will be performed whole blood aggregation test.
Time frame: pre-drug on day 0 and after the 7th daily dose (6 hours for Group 1 and 24 hours for Group 2)
Changes from baseline of proteomic profile of selected angiogenesis factors, ie VEGF, FGF2, TGFbeta, EGF, PDGF, MMP, angiogenin, and angiogenesis inhibitors, ie endostatin, PF4, thrombospondin 1, alpha-macroglobulin, PAI 1 and angiostatin.
It will be done in isolated platelets by using an antibody array kit and Sphingosine-1 Phosphate (S1P) by immunoassay.
Time frame: pre-drug on day 0 and after the 7th daily dose (6 hours for Group 1 and 24 hours for Group 2)
Change from baseline in eicosanoid biosynthesis and protein expression of markers of growth and progression of colorectal cancer (such as COX-2, NF-Kb and PI3K/Akt/mTOR pathway).
It will be done in normal tissues or pathological recto-colonic tissues.
Time frame: pre-drug on day 0 and after the 7th daily dose (6 hours for Group 1 and 24 hours for Group 2)
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Aragon Institute of Health Sciences