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Epigenetic Regulation of Colorectal Polyps and Cancer

NCT06206603 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-04-23

No results posted yet for this study

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

Type of study: clinical trial Participant population Participants consist of patients undergoing a scheduled colonoscopy where a polyp or cancer is discovered. Healthy controls, with normal colonoscopy findings will be enrolled.

Biopsies will be obtained from polyps/cancers and from normal surrounding intestinal mucosa. Biopsies will be obtained from defined intestinal locations from healthy controls. Blood samples will be collected from all participants.

Researchers will compare microRNA/mRNA and microbiota in patients with polyps/cancers and their respective stages as well as healthy controls. Comparisons include biopsies and blood samples.

Conditions

Interventions

DIAGNOSTIC_TEST

Intestinal biopsies

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.

DIAGNOSTIC_TEST

Blood sample

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.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2026-01-31
Completion
2026-04-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206603 on ClinicalTrials.gov