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Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection

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ClinicalTrials.gov Identifier: NCT03146520
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Genomictree, Inc.

Study Description
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Brief Summary:
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.

Condition or disease Intervention/treatment
Colorectal Cancer Polyps Other Cancers Healthy Device: EarlyTect Colon 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
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Study Type : Observational
Actual Enrollment : 634 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
Actual Study Start Date : December 13, 2016
Actual Primary Completion Date : March 18, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Colorectal (CRC)
stage I-IV CRC subjects
 Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
Polyps
subjects with adenoma or polyps
 Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
Other cancers
subjects with other cancers
 Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
Healthy
subjects with no evidence of CRC
 Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Positive ratio of SDC2 methylation in polyps [ Time Frame: 1.5 years ]
    the ratio of SDC2 methylation positive in polyps

  2. Positive ratio of SDC2 methylation in other cancers [ Time Frame: 1.5 years ]
    the ratio of SDC2 methylation positive in other cancers


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria: any one of below can be applicable;

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146520


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Genomictree, Inc.
Severance Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genomictree, Inc.
ClinicalTrials.gov Identifier: NCT03146520     History of Changes
Other Study ID Numbers: 1-2016-0068
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genomictree, Inc.:
Syndecan 2
Methylation biomarker
Colorectal cancer
EarlyTect Colon Cancer test
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases