Colorectal CancerNCT05255588
A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer
An observational study of Colorectal Cancer and Advanced Colorectal Neoplasm, run by Genomictree, Inc. at 1 site in South Korea.
Trial summary
The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Cancer, Advanced Colorectal Neoplasm, Advanced Adenomas
- What is being tested?
- EarlyTect® CRC test
- Type of treatment
- Medical device
- How many people
- 2,358 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2022to 30 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC
Who may be able to join
- Subjects enrolled into the study must meet the following criteria:
- Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening
- Adults aged ≥ 40 years
- Subjects who are at high-risk (Asia Pacific Colorectal Screening (APCS) Score: 4.0~7.0) of developing CRC
- Subjects who are able and willing to undergo colonoscopy screening within 12 months of consent among individuals who reserved a visit in the division of gastroenterology or health check-up.
Who cannot join
- Subjects will be excluded from enrolling into the study if any of the following criteria are met:
- Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening
- Adults aged < 40 years
- Subjects who are not at high-risk (APCS Score ≤ 3.0) of developing CRC
- Subjects who will not undergo colonoscopy screening within 12 months of consent
- Subjects who have had a positive FIT or fecal occult blood test within the previous 2 weeks
Show all 13Show fewer
- Colorectal cancer patients who did not underwent curative treatment
- Subjects who have had a prior history of colorectal resection
- Subjects who have had overt rectal bleeding or melena within the previous 2 weeks
- Subjects who have a family history or a prior history of hereditary CRC or colorectal neoplasm: Lynch syndrome (HNPCC), familial adenomatous polyposis, MUTYH-associated polyposis, Juvenile polyposis syndrome, Peutz-Jeghers syndrome, and serrated polyposis syndrome, etc.
- Subjects who have inflammatory bowel diseases including Crohn's disease, ulcerative colitis or Behcet disease
- Subjects who participated in any "interventional" clinical study within the previous 30 days
- Subject has any condition which, in the opinion of the medical staff should preclude participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® CRC Test for the Early Detection of Colorectal Cancer in the Stool DNA From High-risk Group
The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method.
The secondary objective is to compare the clinical performance of EarlyTect® CRC test with a commercially available Fecal Immunochemical Test (FIT), with respect to CRC. By histopathological examination, lesions identified during colonoscopy will be confirmed as malignant or precancerous by histological examination.
Read the detailed description
A multicenter, single-blind, prospective clinical trial is being conducted to evaluate the clinical performance of EarlyTect® CRC test. Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC who are eligible for inclusion criteria will be asked to collect a stool sample and EarlyTect® CRC and FIT tests will be performed. For confirmation of the diagnosis and tumor staging, representative histopathology slides obtained from curative surgery and representative histopathology slides from tissue biopsied or excised during colonoscopy may be retrieved and examined by the central pathology laboratory. Methylation status of SDC2 in stool DNA is measured by a highly accurate and sensitive real time PCR that employs Linear Target Enrichment (LTE) and quantitative Methylation-Specific PCR (qMSP)(LTE-qMSP).
- Conditions
- Colorectal Cancer, Advanced Colorectal Neoplasm, Advanced Adenomas, Non-neoplastic Polyps, Non-advanced Adenomas
- Being tested
- EarlyTect® CRC test
- Keywords
- Colorectal cancer, SDC2, Methylation biomarker, EarlyTect® CRC test, Stool
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarlyTect® CRC testDevice
A highly accurate and sensitive real time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE/qMSP) for measuring SDC2 methylation in stool DNA to detect CRC.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC aged ≥40 Receives: Device: EarlyTect® CRC test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.
The reference method is the colonoscopy, and lesions will be assessed histopathologically.
EarlyTect® CRC test includes a measurement of SDC2 methylation and COL2A1 as a DNA control. SDC2 methylation in stool DNA will be assessed quantitatively by LTE/qMSP. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100*(positive SDC2 methylation test/positive colonoscopy), Specificity = 100*(negative SDC2 methylation test/negative colonoscopy).
Measured: 18 months
Secondary outcomes (7)
Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma (Adenomas ≥1.0 cm, villous adenomas or high-grade dysplasia)
Sensitivity for detecting adenomas ≥1.0 cm
- Sensitivity of EarlyTect® CRC for detecting villous adenomas
- Sensitivity of EarlyTect® CRC for detecting high-grade dysplasia
Measured: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm
Sensitivity for detecting adenomas ≥1.0 cm
Measured: 18 months
Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas
Sensitivity for detecting non-adenomas <1.0 cm
Measured: 18 months
Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
Measured: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
Measured: 18 months
Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
Measured: 18 months
Clinical sensitivity of the EarlyTect® CRC for detecting Tis
Clinical sensitivity of the EarlyTect® CRC for detecting colorectal cancer with Tis
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start10 Feb 2022
- Primary completion23 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genomictree, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Soon Chun Hyang University, Gangnam Severance Hospital, Kyung Hee University Hospital at Gangdong, Kangbuk Samsung Hospital, Kyung Hee University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Pusan National University Hospital, The Catholic Univ. of Korea Bucheon ST. Mary's Hospital, Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Wonju Severance Christian Hospital, Severance Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255588
- Sponsor's protocol ID
- NEXT-CRC
- Status last verified
- Sep 2024
- First submitted
- 16 Feb 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh TJ, Oh HI, Seo YY, Jeong D, Kim C, Kang HW, Han YD, Chung HC, Kim NK, An S. Feasibility of quantifying SDC2 methylation in stool DNA for early detection of colorectal cancer. Clin Epigenetics. 2017 Dec 4;9:126. doi: 10.1186/s13148-017-0426-3. eCollection 2017.
PubMed 29225717Han YD, Oh TJ, Chung TH, Jang HW, Kim YN, An S, Kim NK. Early detection of colorectal cancer based on presence of methylated syndecan-2 (SDC2) in stool DNA. Clin Epigenetics. 2019 Mar 15;11(1):51. doi: 10.1186/s13148-019-0642-0.
PubMed 30876480
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® CRC Test for the Early Detection of Colorectal Cancer in the Stool DNA From High-risk Group
- ClinicalTrials.gov ID
- NCT05255588
- Acronym / sponsor ID
- NEXT-CRC
- Conditions
- Colorectal Cancer, Advanced Colorectal Neoplasm, Advanced Adenomas, Non-neoplastic Polyps, Non-advanced Adenomas
- Keywords
- Colorectal cancer, SDC2, Methylation biomarker, EarlyTect® CRC test, Stool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,358 participants (actual)
- Lead sponsor
- Genomictree, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Soon Chun Hyang University, Gangnam Severance Hospital, Kyung Hee University Hospital at Gangdong, Kangbuk Samsung Hospital, Kyung Hee University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Pusan National University Hospital, The Catholic Univ. of Korea Bucheon ST. Mary's Hospital, Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Wonju Severance Christian Hospital, Severance Hospital
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 24 Feb 2022 (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 primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method.
The secondary objective is to compare the clinical performance of EarlyTect® CRC test with a commercially available Fecal Immunochemical Test (FIT), with respect to CRC. By histopathological examination, lesions identified during colonoscopy will be confirmed as malignant or precancerous by histological examination.
Detailed description
A multicenter, single-blind, prospective clinical trial is being conducted to evaluate the clinical performance of EarlyTect® CRC test. Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC who are eligible for inclusion criteria will be asked to collect a stool sample and EarlyTect® CRC and FIT tests will be performed. For confirmation of the diagnosis and tumor staging, representative histopathology slides obtained from curative surgery and representative histopathology slides from tissue biopsied or excised during colonoscopy may be retrieved and examined by the central pathology laboratory. Methylation status of SDC2 in stool DNA is measured by a highly accurate and sensitive real time PCR that employs Linear Target Enrichment (LTE) and quantitative Methylation-Specific PCR (qMSP)(LTE-qMSP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Device: EarlyTect® CRC testSubjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC aged ≥40 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC
Key inclusion criteria (5 listed)
- Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening
- Adults aged ≥ 40 years
- Subjects who are at high-risk (Asia Pacific Colorectal Screening (APCS) Score: 4.0~7.0) of developing CRC
- Subjects who are able and willing to undergo colonoscopy screening within 12 months of consent among individuals who reserved a visit in the division of gastroenterology or health check-up.
Key exclusion criteria (13 listed)
- Subjects will be excluded from enrolling into the study if any of the following criteria are met:
- Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening
- Adults aged < 40 years
- Subjects who are not at high-risk (APCS Score ≤ 3.0) of developing CRC
- Subjects who will not undergo colonoscopy screening within 12 months of 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 |
|---|---|---|
| EarlyTect® CRC testA highly accurate and sensitive real time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE/qMSP) for measuring SDC2 methylation in stool DNA to detect CRC. | Device | Cohort |
Primary outcome
Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.
Time frame: 18 months
The reference method is the colonoscopy, and lesions will be assessed histopathologically. EarlyTect® CRC test includes a measurement of SDC2 methylation and COL2A1 as a DNA control. SDC2 methylation in stool DNA will be assessed quantitatively by LTE/qMSP. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100*(positive SDC2 methylation test/positive colonoscopy), Specificity = 100*(negative SDC2 methylation test/negative colonoscopy).
7 secondary outcomes
Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma (Adenomas ≥1.0 cm, villous adenomas or high-grade dysplasia)
Time frame: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm
Time frame: 18 months
Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas
Time frame: 18 months
Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
Time frame: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
Time frame: 18 months
Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
Time frame: 18 months
Clinical sensitivity of the EarlyTect® CRC for detecting Tis
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 29225717Oh TJ, Oh HI, Seo YY, Jeong D, Kim C, Kang HW, Han YD, Chung HC, Kim NK, An S. Feasibility of quantifying SDC2 methylation in stool DNA for early detection of colorectal cancer. Clin Epigenetics. 2017 Dec 4;9:126. doi: 10.1186/s13148-017-0426-3. eCollection 2017.
- Background: PubMed 30876480Han YD, Oh TJ, Chung TH, Jang HW, Kim YN, An S, Kim NK. Early detection of colorectal cancer based on presence of methylated syndecan-2 (SDC2) in stool DNA. Clin Epigenetics. 2019 Mar 15;11(1):51. doi: 10.1186/s13148-019-0642-0.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Advanced Colorectal Neoplasm, run by Genomictree, Inc. at 1 site in South Korea.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 3 Apr 2025. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255588, which also lists 2 linked publications.
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 3 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.