Colorectal CancerNCT04823793
Fecal DNA Methylation Test for Colorectal Cancer Screening
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This is an observational, prospective study using fecal DNA methylation test to define the risk of suffering from advanced adenoma or colorectal cancer (CRC) compared to colonoscopy and fecal immunochemical test (FIT). Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma
- What is being tested?
- Stool DNA methylation detection
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Mar 2021to 20 Mar 2023
- 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 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy group : Participants without any cancerous lesion in their colon Disease group : Participants with adenoma or colorectal cancer
Who may be able to join
- Participants with age over 40 but under 80, who need to take colonoscopy or diagnostic confirmed colorectal cancer patient.
Who cannot join
- Participants who are undergoing cancer treatments or have diagnosed with cancer, received cancer treatment in the past.
- Participants who have received any cancer treatments, including chemotherapy and radiotherapy before taking surgery.
- Participants have received any surgery for colorectal cancer in the past.
- Pregnant women or nursing women.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital, National Defense Medical Center
Taipei
Yi-Chiao Cheng, +886912959022, ndmcjoe@gmail.com
About this study
Official title: A Fecal DNA Methylation Test for Colorectal Cancer Screening Using Multitarget Real-Time PCR Method-A Observational, Prospective Study
This is an observational, prospective study using fecal DNA methylation test to define the risk of suffering from advanced adenoma or colorectal cancer (CRC) compared to colonoscopy and fecal immunochemical test (FIT).
This study recruits at least 80 participants, including 40 people of healthy controls, 20 people with adenoma, and 20 people with CRC, which were confirmed by colonoscopy. All fecal specimens from participants will be examined by FIT and multi-methylated target gene detection through real-time quantitative methylation-specific PCR (qMSP).
The objective of this study is to evaluate the sensitivity and specificity of multi-methylated target PCR compared with the FIT and confirm the examination results through colonoscopy.
Read the detailed description
The incidence rate and the mortality rate of colorectal cancer (CRC) have been steadily increasing worldwide. Early detection of CRC can provide great opportunities to help patients, increasing their 5-year survival rate. Colonoscopy has been considered as the golden standard of CRC screening method, but the invasive procedures cannot be widely adapted by recipients.
Nowadays, the most common CRC screening method is fecal immunochemical test (FIT) which is a cost-effective and non-invasive approach. The sensitivity of FIT for CRC detection is about 80%, but only 20% for adenoma.
The methylation level of candidate genes are determined by qMSP to estimate the risk of colorectal cancer. This study implements fecal DNA methylation test and fecal immunochemical test simultaneously to evaluate whether the fecal DNA methylation test can improve the detection rate of adenoma and CRC.
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Being tested
- Stool DNA methylation detection
- Keywords
- Fecal immunochemical testing, Methylation, Stool, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool DNA methylation detectionDiagnostic test
Stool specimens are collected from participants in the outpatient department or the inpatient department. Both FIT and stool DNA real-time PCR are performed simultaneously. To improve the sensitivity and specificity of the colorectal cancer screening, this study enrolls multiple candidate genes to distinguish whether the participant has a high risk of colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group : Stool specimens from participants with healthy colon | Stool specimens will be collected from participants before having a colonoscopy.
If the participant's colon has a healthy colon without any cancerous lesion, the stool specimen will be included in the healthy group. Receives: Diagnostic Test: Stool DNA methylation detection | |
| Disease group : Stool specimens from participants with adenoma/colorectal cancer | Stool specimens will be collected from participants before having a colonoscopy.
If the participant's colon has precancerous lesion, such as adenoma, the stool specimen will be included in the disease group.
Also, specimens from confirmed colorectal cancer patients are included in the disease group. Receives: Diagnostic Test: Stool DNA methylation detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of methylation biomarker and FIT for adenoma and colorectal cancer screening
In this study, we estimate the sensitivity and specificity of methylation biomarker isolated from participant's stool DNA and perform FIT simultaneously.
The Ct values of candidate genes and GAPDH (reference gene) are determined by real-time PCR. The delta Ct values are calculated by Ct value of candidate gene - Ct value of GAPDH. Furthermore, the cut-off value of each candidate gene was determined based on the Receiver Operating Characteristic curve.
If the value of Fecal immunochemical test is more than 100 ng Hb/ml, the stool is considered as positive with fecal occult blood.
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 posted1 Apr 2021
- Study start31 Mar 2021
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Mar 2023 (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.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Chiao Cheng, Tri-Service General Hospital (TSGH)
- Investigators
- Yi-Chiao Cheng, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823793
- Sponsor's protocol ID
- A202105054
- Status last verified
- Apr 2021
- First submitted
- 15 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fecal DNA Methylation Test for Colorectal Cancer Screening Using Multitarget Real-Time PCR Method-A Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT04823793
- Acronym / sponsor ID
- A202105054
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Keywords
- Fecal immunochemical testing, Methylation, Stool, Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 1 Apr 2021 (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.
This is an observational, prospective study using fecal DNA methylation test to define the risk of suffering from advanced adenoma or colorectal cancer (CRC) compared to colonoscopy and fecal immunochemical test (FIT).
This study recruits at least 80 participants, including 40 people of healthy controls, 20 people with adenoma, and 20 people with CRC, which were confirmed by colonoscopy. All fecal specimens from participants will be examined by FIT and multi-methylated target gene detection through real-time quantitative methylation-specific PCR (qMSP).
The objective of this study is to evaluate the sensitivity and specificity of multi-methylated target PCR compared with the FIT and confirm the examination results through colonoscopy.
Detailed description
The incidence rate and the mortality rate of colorectal cancer (CRC) have been steadily increasing worldwide. Early detection of CRC can provide great opportunities to help patients, increasing their 5-year survival rate. Colonoscopy has been considered as the golden standard of CRC screening method, but the invasive procedures cannot be widely adapted by recipients.
Nowadays, the most common CRC screening method is fecal immunochemical test (FIT) which is a cost-effective and non-invasive approach. The sensitivity of FIT for CRC detection is about 80%, but only 20% for adenoma.
The methylation level of candidate genes are determined by qMSP to estimate the risk of colorectal cancer. This study implements fecal DNA methylation test and fecal immunochemical test simultaneously to evaluate whether the fecal DNA methylation test can improve the detection rate of adenoma and CRC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group : Stool specimens from participants with healthy colon | – | Diagnostic Test: Stool DNA methylation detectionStool specimens will be collected from participants before having a colonoscopy. If the participant's colon has a healthy colon without any cancerous lesion, the stool specimen will be included in the healthy group. |
| Disease group : Stool specimens from participants with adenoma/colorectal cancer | – | Diagnostic Test: Stool DNA methylation detectionStool specimens will be collected from participants before having a colonoscopy. If the participant's colon has precancerous lesion, such as adenoma, the stool specimen will be included in the disease group. Also, specimens from confirmed colorectal cancer patients are included in the disease group. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy group : Participants without any cancerous lesion in their colon Disease group : Participants with adenoma or colorectal cancer
Key inclusion criteria (1 listed)
- Participants with age over 40 but under 80, who need to take colonoscopy or diagnostic confirmed colorectal cancer patient.
Key exclusion criteria (4 listed)
- Participants who are undergoing cancer treatments or have diagnosed with cancer, received cancer treatment in the past.
- Participants who have received any cancer treatments, including chemotherapy and radiotherapy before taking surgery.
- Participants have received any surgery for colorectal cancer in the past.
- Pregnant women or nursing women.
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 |
|---|---|---|
| Stool DNA methylation detectionStool specimens are collected from participants in the outpatient department or the inpatient department. Both FIT and stool DNA real-time PCR are performed simultaneously. To improve the sensitivity and specificity of the colorectal cancer screening, this study enrolls multiple candidate genes to distinguish whether the participant has a high risk of colorectal cancer. | Diagnostic test | Disease group : Stool specimens from participants with adenoma/colorectal cancer, Healthy group : Stool specimens from participants with healthy colon |
Primary outcome
Sensitivity and specificity of methylation biomarker and FIT for adenoma and colorectal cancer screening
Time frame: 6 months
In this study, we estimate the sensitivity and specificity of methylation biomarker isolated from participant's stool DNA and perform FIT simultaneously. The Ct values of candidate genes and GAPDH (reference gene) are determined by real-time PCR. The delta Ct values are calculated by Ct value of candidate gene - Ct value of GAPDH. Furthermore, the cut-off value of each candidate gene was determined based on the Receiver Operating Characteristic curve. If the value of Fecal immunochemical test is more than 100 ng Hb/ml, the stool is considered as positive with fecal occult blood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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.
Yi-Chiao Cheng, MD principal investigator
Tri-Service General Hospital (TSGH)
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 Adenoma, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 4 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 8 Apr 2021. 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 Taiwan. 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 Yi-Chiao Cheng, MD (+886912959022, ndmcjoe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of methylation biomarker and FIT for adenoma and colorectal cancer screening (time frame: 6 months). 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 8 Apr 2021.