A Phase 2 interventional study of Mesalazine in Colorectal Cancer, sponsored by SOFAR S.p.A.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-02.
Sponsored by SOFAR S.p.A. · Phase 2, Interventional, and Treatment
The purpose of this study is to obtain an "in vivo" confirmation that mesalazine induces the gene expression of μ-protocadherin and other related genes in the colon mucosa, as demonstrated in some "in vitro" experiments. .
Pilot Trial, single-blind, parallel group on biopsy specimens of healthy colon mucosa in patients with precancerous lesions of the colon and rectum (adenomas) treated with mesalazine.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 21 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →SOFAR S.p.A. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The following inclusion criteria was deleted according to Amendment n. 01 approved by the Ethical Committee on 19/dec/2014:
The rationale of this change is that the presence of diverticular disease/diverticular colitis does not contribute to the definition of the trial primary end-points and represents a critical point during the patient selection with an impact on duration and conduction of the study.
Exclusion Criteria:
Mesalazine 800 mg orally t.i.d for 3 months
Drug: Mesalazine
no treatment
Mesalazine cpr 800 mg t.i.d. for 3 months
Also known as: 5-aminosalicylic acid, 5-ASA, Pentacol
Molecular analysis of gene expression levels of μ-protocadherin and other related proteins
Molecular analysis (quantitative RT-PCR) of gene expression levels of μ-protocadherin, protocadherin 19, protocadherin 24, cadherin E, TCF7L2, TCF4, c-myc, Cyclin D1, p21waf1, VEGF, CD44, Met, KLF4 e CEBP-α and comparison of the levels assessed at the end of the treatment period with the baseline.
Time frame: 3 months
Evaluation of protein expression level of μ-protocadherin, Ki-67, Caspase-3 and Histone H2AXγ, evaluation of DNA oxidative damage and intra-mucosal concentration of 5-Acetylsalicylic acid
These parameters will be examined using molecular analysis of the oxidation and depurination levels of the DNA and chromatographic analysis of the intra-mucosal concentration of 5-Acetylsalicylic acid, in biopsies of normal mucosa of the colon taken before and after the treatment of patients with 5-Acetylsalicylic acid: * quantification of the percentage of cells expressing the following proteins by immunohistochemical analysis: μ-protocadherin, Ki-67, Caspase-3 and Histone H2AXγ; * quantification of number of AP sites per 100000 DNA bp * quantification of nanograms di 8-OhdG (8-hydroxyguanine) per micrograms of DNA
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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SOFAR S.p.A.