Colorectal CancerNCT06206603
Epigenetic Regulation of Colorectal Polyps and Cancer
An observational study of Colorectal Cancer and Colorectal Polyp, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma
- What is being tested?
- Intestinal biopsies and Blood sample
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 3 Jan 2024to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred for colonoscopy.
Who may be able to join
- Patients over 18 years referred for colonoscopy for examination or evaluation/removal of colorectal polyps.
Who cannot join
- Patients with a history of colorectal cancer.
- Patients not in capacity to understand the study information and give informed consent.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital, Malmö, section of Surgery
Malmö, Skåne County, 20501
Carl-Fredrik Rönnow, MD, PhD, +46 40-331635, carl-fredrik.ronnow@med.lu.se
Henrik Thorlacius, Professor, +46 40-331000, henrik.thorlacius@med.lu.se
About this study
Official title: Epigenetic Regulation of Colorectal Polyps and Cancer and Its Traceability in Blood
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:
Read more
- Are there specific microRNA/mRNA that are expressed in different types of polyps and cancers and their respective stages?
- Is microRNA/mRNA expression in polyps and cancer traceable in blood from the same patient?
- 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.
Read the 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 microRNA/mRNA 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 microRNA/mRNA alterations responsible for the evolvement of colorectal polyps and cancer as well as to trace specific microRNA/mRNA 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 polyps/cancer, as well as their respective microRNA/mRNA profiles.
Primary Research Questions
Are there specific microRNA/mRNA expressions in different types of polyps/cancer and at different stages of development?
Does microRNA/mRNA expression in polyps/cancer correlate with microRNA/mRNA in the patient's blood?
Secondary Research Question Does the intestinal microbiota correlate with the presence of polyps and cancer, and their microRNA/mRNA 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 microRNA/mRNA from biopsies taken from polyps, cancer, surrounding intestinal mucosa and healthy controls, and to trace these in the patient's blood. Additionally, the study will analyze the microbiota from the intestinal biopsies to investigate its role in the expression of various microRNA/mRNA. 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 microRNA/mRNA 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.
- Being tested
- Intestinal biopsies, Blood sample
- Keywords
- Colorectal cancer, Colorectal polyps
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal biopsiesDiagnostic 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.
Blood sampleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Intestinal biopsies; Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA/mRNA expression in polyps and cancer
Investigate specific microRNA/mRNA expressions in different types of polyps/cancer and at different stages of development
Measured: 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
Measured: 6 months
Secondary outcomes (1)
Correlation of Intestinal microbiota and microRNA/mRNA expression
Investigate whether the intestinal microbiota correlate with the presence of polyps and cancer, and their microRNA/mRNA expression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start3 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206603
- Sponsor's protocol ID
- EPIPOL
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Regulation of Colorectal Polyps and Cancer and Its Traceability in Blood
- ClinicalTrials.gov ID
- NCT06206603
- Acronym / sponsor ID
- EPIPOL
- Keywords
- Colorectal cancer, Colorectal polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Jan 2024 (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 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:
- Are there specific microRNA/mRNA that are expressed in different types of polyps and cancers and their respective stages?
- Is microRNA/mRNA expression in polyps and cancer traceable in blood from the same patient?
- 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.
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 microRNA/mRNA 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 microRNA/mRNA alterations responsible for the evolvement of colorectal polyps and cancer as well as to trace specific microRNA/mRNA 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 polyps/cancer, as well as their respective microRNA/mRNA profiles.
Primary Research Questions
Are there specific microRNA/mRNA expressions in different types of polyps/cancer and at different stages of development?
Does microRNA/mRNA expression in polyps/cancer correlate with microRNA/mRNA in the patient's blood?
Secondary Research Question Does the intestinal microbiota correlate with the presence of polyps and cancer, and their microRNA/mRNA 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 microRNA/mRNA from biopsies taken from polyps, cancer, surrounding intestinal mucosa and healthy controls, and to trace these in the patient's blood. Additionally, the study will analyze the microbiota from the intestinal biopsies to investigate its role in the expression of various microRNA/mRNA. 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 microRNA/mRNA 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorectal polyps | – | Diagnostic Test: Intestinal biopsies, Diagnostic Test: Blood sampleBiopsies 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. |
| Colorectal cancer | – | Diagnostic Test: Intestinal biopsies, Diagnostic Test: Blood sampleBiopsies 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. |
| Healthy controls | – | Diagnostic Test: Intestinal biopsies, Diagnostic Test: Blood sampleBiopsies 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for colonoscopy.
Key inclusion criteria (1 listed)
- Patients over 18 years referred for colonoscopy for examination or evaluation/removal of colorectal polyps.
Key exclusion criteria (2 listed)
- Patients with a history of colorectal cancer.
- Patients not in capacity to understand the study information and give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal biopsiesApproximately 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 | Colorectal cancer, Colorectal polyps, Healthy controls |
| Blood sampleA 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. | Diagnostic test | Colorectal cancer, Colorectal polyps, Healthy controls |
Primary outcome
microRNA/mRNA expression in polyps and cancer
Time frame: 6 months
Investigate specific microRNA/mRNA expressions in different types of polyps/cancer and at different stages of development
Traceability of microRNA/mRNA expression of polyps and cancer in blood
Time frame: 6 months
Investigate whether microRNA/mRNA expression in polyps/cancer correlate with microRNA/mRNA in the patient's blood
1 secondary outcome
Correlation of Intestinal microbiota and microRNA/mRNA expression
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Colorectal Cancer and Colorectal Polyp, run by Region Skane at 1 site in Sweden.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl-Fredrik Rönnow, MD, PhD (+46768081218, carl-fredrik.ronnow@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA/mRNA expression in polyps and cancer (time frame: 6 months). The study lists 2 primary outcomes in all. 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 23 Apr 2024.