KLF4 Epigenetic Modulation
KLF4 Methylation · Epigenetic
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 170 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Patients undergoing routine colonoscopy
- \> 18 years of age
- Diagnosed by S.C. Anatomia Patologica, AUSL-IRCCS Reggio Emilia
Exclusion Criteria:
- Concomitant diagnosis of colorectal carcinoma
Study population
The samples are represented by endoscopic specimens collected only during routine exams.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
Site-specific KLF4 methylation
Time frame: 24 months
Evaluation of site-specific KLF4 DNA methylation in colorectal tissue samples using molecular approaches based on bisulfite conversion and PCR analysis.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyRecruiting
Study team and timeline
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Study start
- Oct 30, 2026 Actual
- Primary completion
- 2027-07 Estimated
- Study completion
- 2028-07 Estimated
- First posted
- Oct 28, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
KLF4 Epigenetic Modulation During Polyps-adenoma Progression
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026