Colorectal CancerNCT03146520
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
An observational study of Colorectal Cancer and Polyps, run by Genomictree, Inc. at 1 site in South Korea.
Trial summary
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Polyps, Other Cancers
- What is being tested?
- EarlyTect Colon Cancer
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 634 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2016to 30 Mar 2018
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have colorectal cancer or pre-malignancy or benign polyp or other solid tumor, or healthy normal subjects, and confirmed by colonoscopy or pathological examination.
Who may be able to join
- sample information is complete, including sample number, gender, family history, stage of cancer, treatment history, and other disease information
- the CRC patient who has not any treatment (surgery, chemotherapy, or radiation)
- non-CRC patient who has not received any treatment (surgery, chemotherapy, or radiation) within the last 6 months
- all of above conditions are satisfied, and any one of below can be applicable; 1) confirm to be CRC with colonoscopy and/or pathological examination, 2) confirm to be inflammatory or ulcerative bowel diseases or benign hyperplastic polyp, 3) confirm to be gastrointestinal or liver cancers who are not CRC, 4) schedule to receive colonoscopy and additional confirmation test for CRC with agreement to provide the test results.
Who cannot join
- the patient information is not complete and/or does not satisfy inclusion criteria
- the sample information is not complete and/or does not satisfy inclusion criteria
- the CRC patient who has history of colorectal cancer surgery, chemotherapy, or any other treatment
- non-CRC patient who received any chemotherapy within the last 6 months
- the patient who has limited ability or are vulnerable to accept clinical trial agreement
- the patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.
Read the detailed description
The purpose of this study is to validate the clinical performance of EarlyTect Colon Cancer test which is measuring Syndecan 2 methylation status in stool DNA to detect CRC. Syndecan 2 (SDC2) is a newly developed methylation biomarker for colorectal cancer diagnosis. Methylation status of SDC2 gene in stool DNA is determined by methylation specific qPCR. Sensitivity and specificity will be determined by comparing Stool DNA test from healthy subjects, CRC patients, and other group including polyps and other diseases.
- Conditions
- Colorectal Cancer, Polyps, Other Cancers, Healthy
- Being tested
- EarlyTect Colon Cancer
- Keywords
- Syndecan 2, Methylation biomarker, Colorectal cancer, EarlyTect Colon Cancer test
- Medical subject headings
- Colorectal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarlyTect Colon CancerDevice
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
| Study group | Role | What they receive |
|---|---|---|
| Colorectal (CRC) | stage I-IV CRC subjects Receives: Device: EarlyTect Colon Cancer | |
| Polyps | subjects with adenoma or polyps Receives: Device: EarlyTect Colon Cancer | |
| Other cancers | subjects with other cancers Receives: Device: EarlyTect Colon Cancer | |
| Healthy | subjects with no evidence of CRC Receives: Device: EarlyTect Colon Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer
Sensitivity and specificity of EarlyTect Colon Cancer to detect colorectal cancer (sensitivity: the ratio of positive cases in all CRC cases, specificity: the ratio of negative cases in all healthy controls)
Measured: 1.5 years
Secondary outcomes (2)
Positive ratio of SDC2 methylation in polyps
the ratio of SDC2 methylation positive in polyps
Measured: 1.5 years
Positive ratio of SDC2 methylation in other cancers
the ratio of SDC2 methylation positive in other cancers
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start13 Dec 2016
- Primary completion18 Mar 2018
- Study completion30 Mar 2018
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
- Case-control
- Time perspective
- Other
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genomictree, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146520
- Sponsor's protocol ID
- 1-2016-0068
- Status last verified
- Apr 2018
- First submitted
- 7 May 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh T, Kim N, Moon Y, Kim MS, Hoehn BD, Park CH, Kim TS, Kim NK, Chung HC, An S. Genome-wide identification and validation of a novel methylation biomarker, SDC2, for blood-based detection of colorectal cancer. J Mol Diagn. 2013 Jul;15(4):498-507. doi: 10.1016/j.jmoldx.2013.03.004. Epub 2013 Jun 7.
PubMed 23747112Han 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 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03146520
- Acronym / sponsor ID
- 1-2016-0068
- Conditions
- Colorectal Cancer, Polyps, Other Cancers, Healthy
- Keywords
- Syndecan 2, Methylation biomarker, Colorectal cancer, EarlyTect Colon Cancer test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Genomictree, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 18 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 10 May 2017 (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.
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.
Detailed description
The purpose of this study is to validate the clinical performance of EarlyTect Colon Cancer test which is measuring Syndecan 2 methylation status in stool DNA to detect CRC. Syndecan 2 (SDC2) is a newly developed methylation biomarker for colorectal cancer diagnosis. Methylation status of SDC2 gene in stool DNA is determined by methylation specific qPCR. Sensitivity and specificity will be determined by comparing Stool DNA test from healthy subjects, CRC patients, and other group including polyps and other diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Colorectal (CRC) | – | Device: EarlyTect Colon Cancerstage I-IV CRC subjects |
| Polyps | – | Device: EarlyTect Colon Cancersubjects with adenoma or polyps |
| Other cancers | – | Device: EarlyTect Colon Cancersubjects with other cancers |
| Healthy | – | Device: EarlyTect Colon Cancersubjects with no evidence of CRC |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have colorectal cancer or pre-malignancy or benign polyp or other solid tumor, or healthy normal subjects, and confirmed by colonoscopy or pathological examination.
Key inclusion criteria (4 listed)
- sample information is complete, including sample number, gender, family history, stage of cancer, treatment history, and other disease information
- the CRC patient who has not any treatment (surgery, chemotherapy, or radiation)
- non-CRC patient who has not received any treatment (surgery, chemotherapy, or radiation) within the last 6 months
- all of above conditions are satisfied, and any one of below can be applicable; 1) confirm to be CRC with colonoscopy and/or pathological examination, 2) confirm to be inflammatory or ulcerative bowel diseases or benign hyperplastic polyp, 3) confirm to be gastrointestinal or liver cancers who are not CRC, 4) schedule to receive colonoscopy and additional confirmation test for CRC with agreement to provide the test results.
Key exclusion criteria (6 listed)
- the patient information is not complete and/or does not satisfy inclusion criteria
- the sample information is not complete and/or does not satisfy inclusion criteria
- the CRC patient who has history of colorectal cancer surgery, chemotherapy, or any other treatment
- non-CRC patient who received any chemotherapy within the last 6 months
- the patient who has limited ability or are vulnerable to accept clinical trial agreement
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 Colon CancerSDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit | Device | Colorectal (CRC), Healthy, Other cancers, Polyps |
Primary outcome
Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer
Time frame: 1.5 years
Sensitivity and specificity of EarlyTect Colon Cancer to detect colorectal cancer (sensitivity: the ratio of positive cases in all CRC cases, specificity: the ratio of negative cases in all healthy controls)
2 secondary outcomes
Positive ratio of SDC2 methylation in polyps
Time frame: 1.5 years
Positive ratio of SDC2 methylation in other cancers
Time frame: 1.5 years
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 18 Apr 2018.
- Background: PubMed 23747112Oh T, Kim N, Moon Y, Kim MS, Hoehn BD, Park CH, Kim TS, Kim NK, Chung HC, An S. Genome-wide identification and validation of a novel methylation biomarker, SDC2, for blood-based detection of colorectal cancer. J Mol Diagn. 2013 Jul;15(4):498-507. doi: 10.1016/j.jmoldx.2013.03.004. Epub 2013 Jun 7.
- Derived from this study: 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
Related trials for Colorectal Cancer
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Active, not recruitingPhase 3
Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
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 Polyps, 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 4 inclusion and 6 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 18 Apr 2018. 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?
Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer (time frame: 1.5 years). 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 NCT03146520, 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 18 Apr 2018; AzTrials last refreshed its copy on 26 Oct 2026.