Epigenetic Regulation of Colorectal Polyps and Cancer

NCT06206603 | Recruiting

• 1 other identifier: EPIPOL
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn about the epigenetic and genetic regulation (microRNA/mRNA) of colorectal polyps and their evolvement as polyps and to colorectal cancer. Furthermore, the study aims at investigating whether certain epigenetic features, linked to polyps and/or cancer are traceable in blood samples. The main questions the study aims to answer are:

1. 1.Are there specific microRNA/mRNA that are expressed in different types of polyps and cancers and their respective stages?
2. 2.Is microRNA/mRNA expression in polyps and cancer traceable in blood from the same patient?
3. 3.Is the intestinal microbiata correlated with colorectal polyps and cancer and their microRNA/mRNA expression?

Conditions

Colorectal Cancer; Colorectal Polyp; Colorectal Adenoma; Colorectal Neoplasms

Keywords

Colorectal cancer; Colorectal polyps

Outcome Measures

Primary Outcomes (2)

• microRNA/mRNA expression in polyps and cancer

  Investigate specific microRNA/mRNA expressions in different types of polyps/cancer and at different stages of development

  6 months

• Traceability of microRNA/mRNA expression of polyps and cancer in blood

  Investigate whether microRNA/mRNA expression in polyps/cancer correlate with microRNA/mRNA in the patient's blood

  6 months

Secondary Outcomes (1)

• Correlation of Intestinal microbiota and microRNA/mRNA expression

  6 months

Study Arms (3)

Colorectal polyps

Biopsies will be obtained from the polyp and from adjacent healthy intestinal mucosa. A blood sample will be collected to investigate if certain microRNA/mRNA profiles are traceable in the blood.

Diagnostic Test: Intestinal biopsies; Diagnostic Test: Blood sample

Colorectal cancer

Biopsies will be obtained from the cancer and from adjacent healthy intestinal mucosa. A blood sample will be collected to investigate if certain microRNA/mRNA profiles are traceable in the blood.

Diagnostic Test: Intestinal biopsies; Diagnostic Test: Blood sample

Healthy controls

Biopsies will be obtained from predefined locations in the colon and rectum. A blood sample will be collected to investigate if certain microRNA/mRNA profiles are traceable in the blood.

Diagnostic Test: Intestinal biopsies; Diagnostic Test: Blood sample

Interventions

Intestinal biopsies DIAGNOSTIC_TEST

Approximately 6 biopsies (each around 2-3mm in size) are taken from the polyp or cancer, as well as adjacent healthy intestinal mucosa, during a scheduled colonoscopy. For healthy controls, around 6 biopsies are taken from the healthy intestinal mucosa. The intestinal biopsies are frozen at -80 degrees Celsius.

Colorectal cancer; Colorectal polyps; Healthy controls

Blood sample DIAGNOSTIC_TEST

A venous blood sample (10ml) will be taken in connection with the colonoscopy. Patients typically receive an intravenous needle for the administration of sedatives and pain-relieving medications during the colonoscopy, so the current blood sample does not cause any additional needle sticks or discomfort for the patient. The blood sample is centrifuged, and the plasma is frozen at -80 degrees Celsius.

Colorectal cancer; Colorectal polyps; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for colonoscopy.

You may qualify if:

• Patients over 18 years referred for colonoscopy for examination or evaluation/removal of colorectal polyps.

You may not qualify if:

• Patients with a history of colorectal cancer.
• Patients not in capacity to understand the study information and give informed consent.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital, Malmö, section of Surgery

Malmo, Skåne County, 20501, Sweden

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Carl-Fredrik Rönnow, MD, PhD

CONTACT

+46768081218; carl-fredrik.ronnow@med.lu.se

Henrik Thorlacius, MD, PhD

CONTACT

+46703455150; henrik.thorlacius@med.lu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: January 3, 2024
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-01

Locations

SE (1)