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Trial record 3 of 5036 for:    colon cancer

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.

Tracking Information
First Submitted Date May 7, 2017
First Posted Date May 10, 2017
Last Update Posted Date April 18, 2018
Actual Study Start Date December 13, 2016
Actual Primary Completion Date March 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2017)
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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03146520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 9, 2017)
  • Positive ratio of SDC2 methylation in polyps [ Time Frame: 1.5 years ]
    the ratio of SDC2 methylation positive in polyps
  • Positive ratio of SDC2 methylation in other cancers [ Time Frame: 1.5 years ]
    the ratio of SDC2 methylation positive in other cancers
Original Secondary Outcome Measures
 (submitted: May 7, 2017)
  • Positive rate of EarlyTect Colon Cancer in polyps [ Time Frame: 1.5 years ]
    the ratio of positive cases in polyp cases
  • Positive rate of EarlyTect Colon Cancer in other cancers [ Time Frame: 1.5 years ]
    the ratio of positive cases in other cancer cases
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
Official Title Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Colorectal Cancer
  • Polyps
  • Other Cancers
  • Healthy
Intervention Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
Study Groups/Cohorts
  • Colorectal (CRC)
    stage I-IV CRC subjects
    Intervention: Device: EarlyTect Colon Cancer
  • Polyps
    subjects with adenoma or polyps
    Intervention: Device: EarlyTect Colon Cancer
  • Other cancers
    subjects with other cancers
    Intervention: Device: EarlyTect Colon Cancer
  • Healthy
    subjects with no evidence of CRC
    Intervention: Device: EarlyTect Colon Cancer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2018)
634
Original Estimated Enrollment
 (submitted: May 7, 2017)
626
Actual Study Completion Date March 30, 2018
Actual Primary Completion Date March 18, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03146520
Other Study ID Numbers 1-2016-0068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Genomictree, Inc.
Study Sponsor Genomictree, Inc.
Collaborators Severance Hospital
Investigators Not Provided
PRS Account Genomictree, Inc.
Verification Date April 2018