An observational study in KLF4 Methylation and Epigenetic, sponsored by Azienda USL Reggio Emilia - IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Observational
The study investigates the epigenetic regulation of KLF4 during the progression from colorectal polyps to adenomas and carcinomas. Quantitative KLF4 methylation will be assessed in colorectal tissue samples obtained during routine colonoscopy, together with KLF4 gene expression and its correlation with methylation status in matched tissue samples. The study will also evaluate quantitative and site-specific molecular approaches for the assessment of KLF4 methylation.
Colorectal cancer is one of the most frequently diagnosed cancers worldwide. Colorectal polyps and adenomas represent precursor lesions that may undergo malignant transformation. KLF4 is a transcription factor involved in the regulation of cellular processes and has been described as having context-dependent roles in cancer development. Its activity may be regulated by epigenetic mechanisms, including DNA methylation. The purpose of this prospective observational study is to investigate the epigenetic regulation of KLF4 during the progression from colorectal polyps to adenomas and carcinomas. The primary objective is to assess quantitative KLF4 methylation across different stages of colorectal tissue progression. Secondary objectives are to investigate quantitative and site-specific molecular approaches for the assessment of KLF4 methylation and to assess KLF4 gene expression and its correlation with KLF4 methylation in matched tissue samples.
The study is monocentric and will be conducted at AUSL-IRCCS Reggio Emilia. Participants will be adults undergoing routine colonoscopy and diagnosed by the Pathology Division of AUSL-IRCCS Reggio Emilia. Only tissue samples obtained during routine diagnostic procedures and accompanied by signed informed consent will be included. The research procedures will not affect the diagnostic procedures.
Colorectal tissue samples will be processed as formalin-fixed, paraffin-embedded (FFPE) sections. Genomic DNA and total RNA will be extracted from the samples. DNA methylation will be assessed following bisulfite conversion and specific bisulfite PCR using quantitative PCR approaches. KLF4 gene expression will be assessed by real-time quantitative PCR. Molecular data will be recorded in a study database.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 170 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 93 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The samples are represented by endoscopic specimens collected only during routine exams.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
KLF4 DNA methylation
Quantitative assessment of KLF4 DNA methylation in colorectal tissue samples representing different stages of colorectal polyp-adenoma-carcinoma progression. KLF4 methylation will be assessed using bisulfite conversion followed by specific PCR.
Time frame: 24 months
Site-specific KLF4 methylation
Evaluation of site-specific KLF4 DNA methylation in colorectal tissue samples using molecular approaches based on bisulfite conversion and PCR analysis.
Time frame: 24 months
Started Oct 2026 (actual). Primary completion is estimated for Jul 2027, 9 months after the start.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 9 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda USL Reggio Emilia - IRCCS