Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206603
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-04
Brief Title:
Epigenetic Regulation of Colorectal Polyps and Cancer
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Epigenetic Regulation of Colorectal Polyps and Cancer and Its Traceability in Blood
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn about the epigenetic and genetic regulation microRNAmRNA 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 andor cancer are traceable in blood samples
The main questions the study aims to answer are
1 Are there specific microRNAmRNA that are expressed in different types of polyps and cancers and their respective stages
2 Is microRNAmRNA 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 microRNAmRNA 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 polypscancers 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 microRNAmRNA and microbiota in patients with polypscancers and their respective stages as well as healthy controls Comparisons include biopsies and blood samples
The main questions the study aims to answer are
1 Are there specific microRNAmRNA that are expressed in different types of polyps and cancers and their respective stages
2 Is microRNAmRNA 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 microRNAmRNA 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 polypscancers 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 microRNAmRNA and microbiota in patients with polypscancers and their respective stages as well as healthy controls Comparisons include biopsies and blood samples
Detailed Description:
Scientific Question The study aims to investigate the epigenetic regulation of polyps in the colon and rectum in patients undergoing colonoscopy The intention is to examine the expression of microRNAmRNA in blood and intestinal tissue in patients with colorectal polyps or colorectal cancer as well as in healthy controls The goal is to learn more about microRNAmRNA alterations responsible for the evolvement of colorectal polyps and cancer as well as to trace specific microRNAmRNA expression from polyps and cancer in the blood Furthermore the study will analyze the microbiome of the intestines to explore potential associations between the gut microbiota and polypscancer as well as their respective microRNAmRNA profiles
Primary Research Questions
Are there specific microRNAmRNA expressions in different types of polypscancer and at different stages of development
Does microRNAmRNA expression in polypscancer correlate with microRNAmRNA in the patients blood
Secondary Research Question Does the intestinal microbiota correlate with the presence of polyps and cancer and their microRNAmRNA expression
Background Colorectal cancer is the third most frequent cancer and the second most frequent cause of cancer related death world-wide Polyps are precursor lesions to colorectal cancer and the transition from polyps to cancer involves the accumulation of various epigenetic and genetic changes which is described to take approximately 10-15 years Screening for colorectal cancer is essential as it has been shown to reduce both morbidity and mortality However current screening modalities including colonoscopy and faecal occult blood tests are challenging because of low compliance There is currently no blood-based screening test for colorectal cancer and polyps Understanding microRNA non-coding RNA molecules has opened up the possibility of developing such a test MicroRNA with its regulatory role in gene expression could serve as a biomarker in the blood for colorectal polyps and cancer
Project Description Design Clinical Trial The study plans to recruit 400 patients over approximately 24-48 months The aim is to analyze microRNAmRNA from biopsies taken from polyps cancer surrounding intestinal mucosa and healthy controls and to trace these in the patients blood Additionally the study will analyze the microbiota from the intestinal biopsies to investigate its role in the expression of various microRNAmRNA A pilot study will analyze samples from 5-20 patients and an interim analysis will occur after including 50-100 patients Patients over 18 years referred for colonoscopy will be asked to participate in the study
Inclusion
Patients with colorectal polyps approximately 150 patients Patients with colorectal cancer approximately 150 patients Healthy controls with no mucosal changes during colonoscopy approximately 100 patients
Ethical Considerations Participation is not directly beneficial to included patients but the knowledge we anticipate to gain from the study will hopefully it contribute to future advancements in the treatment and diagnosis of colorectal polyps and cancer No risks are anticipated as intestinal biopsies and blood samples are routine procedures in healthcare
Significance In-depth information on different microRNAmRNA expressions in colorectal polyps and cancer is expected to provide crucial knowledge leading to new diagnostic tools treatment alternatives and preventive measures The study aims to establish biomarkers for blood-based screening of colorectal polyps and cancer potentially reducing the incidence morbidity and mortality of colorectal cancer The study will also investigate the significance of the microbiota in the development of polyps and cancer aiming to contribute valuable information for understanding colorectal cancer development and potential preventive measures
Primary Research Questions
Are there specific microRNAmRNA expressions in different types of polypscancer and at different stages of development
Does microRNAmRNA expression in polypscancer correlate with microRNAmRNA in the patients blood
Secondary Research Question Does the intestinal microbiota correlate with the presence of polyps and cancer and their microRNAmRNA expression
Background Colorectal cancer is the third most frequent cancer and the second most frequent cause of cancer related death world-wide Polyps are precursor lesions to colorectal cancer and the transition from polyps to cancer involves the accumulation of various epigenetic and genetic changes which is described to take approximately 10-15 years Screening for colorectal cancer is essential as it has been shown to reduce both morbidity and mortality However current screening modalities including colonoscopy and faecal occult blood tests are challenging because of low compliance There is currently no blood-based screening test for colorectal cancer and polyps Understanding microRNA non-coding RNA molecules has opened up the possibility of developing such a test MicroRNA with its regulatory role in gene expression could serve as a biomarker in the blood for colorectal polyps and cancer
Project Description Design Clinical Trial The study plans to recruit 400 patients over approximately 24-48 months The aim is to analyze microRNAmRNA from biopsies taken from polyps cancer surrounding intestinal mucosa and healthy controls and to trace these in the patients blood Additionally the study will analyze the microbiota from the intestinal biopsies to investigate its role in the expression of various microRNAmRNA A pilot study will analyze samples from 5-20 patients and an interim analysis will occur after including 50-100 patients Patients over 18 years referred for colonoscopy will be asked to participate in the study
Inclusion
Patients with colorectal polyps approximately 150 patients Patients with colorectal cancer approximately 150 patients Healthy controls with no mucosal changes during colonoscopy approximately 100 patients
Ethical Considerations Participation is not directly beneficial to included patients but the knowledge we anticipate to gain from the study will hopefully it contribute to future advancements in the treatment and diagnosis of colorectal polyps and cancer No risks are anticipated as intestinal biopsies and blood samples are routine procedures in healthcare
Significance In-depth information on different microRNAmRNA expressions in colorectal polyps and cancer is expected to provide crucial knowledge leading to new diagnostic tools treatment alternatives and preventive measures The study aims to establish biomarkers for blood-based screening of colorectal polyps and cancer potentially reducing the incidence morbidity and mortality of colorectal cancer The study will also investigate the significance of the microbiota in the development of polyps and cancer aiming to contribute valuable information for understanding colorectal cancer development and potential preventive measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None