KLF4 MethylationPOLYEPNCT07901335
KLF4 Epigenetic Modulation
An observational study of KLF4 Methylation and Epigenetic, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KLF4 Methylation, Epigenetic
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The samples are represented by endoscopic specimens collected only during routine exams.
Who may be able to join
- Patients undergoing routine colonoscopy
- > 18 years of age
- Diagnosed by S.C. Anatomia Patologica, AUSL-IRCCS Reggio Emilia
Who cannot join
- Concomitant diagnosis of colorectal carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
Raffaele Frazzi, PhD, 0522 295777, raffaele.frazzi@ausl.re.it
About this study
Official title: KLF4 Epigenetic Modulation During Polyps-adenoma Progression
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.
Read the detailed description
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.
- Conditions
- KLF4 Methylation, Epigenetic
- Keywords
- colorectal cancer, gene expression, colorectal polyps, colorectal tissue
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KLF4 MethylationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901335
- Sponsor's protocol ID
- 340/2026/TESS/IRCCSRE
- Acronym
- POLYEP
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KLF4 Epigenetic Modulation During Polyps-adenoma Progression
- ClinicalTrials.gov ID
- NCT07901335
- Acronym / sponsor ID
- POLYEP / 340/2026/TESS/IRCCSRE
- Conditions
- KLF4 Methylation, Epigenetic
- Keywords
- colorectal cancer, gene expression, colorectal polyps, colorectal tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The samples are represented by endoscopic specimens collected only during routine exams.
Key inclusion criteria (3 listed)
- Patients undergoing routine colonoscopy
- > 18 years of age
- Diagnosed by S.C. Anatomia Patologica, AUSL-IRCCS Reggio Emilia
Key exclusion criteria (1 listed)
- Concomitant diagnosis of colorectal carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KLF4 DNA methylation
Time frame: 24 months
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.
1 secondary outcome
Site-specific KLF4 methylation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of KLF4 Methylation and Epigenetic, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KLF4 DNA methylation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.