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Trial record 2 of 128 for:    Methylation Sciences

CRC Screening Using mSEPT9 (Methylated Septin 9) in Chinese Population (RESEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540850
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Collaborators:
Peking Union Medical College Hospital
General Hospital of Beijing PLA Military Region
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Cancer Hospital
Information provided by (Responsible Party):
BioChain (Beijing) Science and Technology, Inc.

Brief Summary:
The purpose of this study is to evaluate the performance of the SEPT9 gene methylation assay in Colorectal cancer (CRC) high-risk population in Chinese hospitals using the opportunistic screening method. The trial plans to evaluate a Chinese domestic SEPT9 assay kit produced by BioChain (Beijing) Science and Technology Corporation, who is a close partner of Epigenomics AG, the producer for Epi proColon 2.0 CE.

Condition or disease
Colorectal Cancer Adenomatous Polyp of Colon Polyps Other Disease/Injury Other Cancers

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Study Type : Observational
Actual Enrollment : 1031 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of Colorectal Cancer Using Improved SEPT9 (Septin 9) Gene Methylation Assay in Chinese Population
Study Start Date : February 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Group/Cohort
CRC group
stage 0-IV CRC subjects
precancerous disease group
subjects with adenoma or polyps
other disease group
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease



Primary Outcome Measures :
  1. Ct Value (Ct Values From PCR Reaction) [ Time Frame: 1 year ]
    the number of PCR cycles where the amplification signal starts to be observed


Secondary Outcome Measures :
  1. Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer) [ Time Frame: 1 year ]
    the ratio of positive cases in all CRC cases

  2. Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases)) [ Time Frame: 1 year ]
    the ratio of negative cases in all non-CRC or NED cases

  3. PPV (the Positive Predictive Value of mSEPT9 Assay in the Population) [ Time Frame: 1 year ]
    the ratio of true positive in all positive cases

  4. NPV (the Negative Predictive Value of mSEPT9 Assay in the Population) [ Time Frame: 1 year ]
    the ratio of true negative in all negative cases

  5. Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population) [ Time Frame: 1 year ]
    the ratio of positive cases in all cases

  6. Consistency (the Overall Ratio of True Positive and True Negative) [ Time Frame: 1 year ]
    The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases



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Ages Eligible for Study:   17 Years to 88 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All eligible inpatients, outpatients, and subjects from health examination centers.
Criteria

Inclusion Criteria:

  1. sample information is complete, including sample number, gender, age and clinical diagnosis;
  2. CRC group: positive samples refer to samples confirmed to be CRC with colonoscopy and/or pathological examination;
  3. precancerous disease group: all samples confirmed to be adenoma and polyps by colonoscopy and/or pathological examination
  4. other disease group: samples confirmed to be other GI diseases, other cancers or no evidence of diseases by colonoscopy and/or pathological examination

Exclusion Criteria:

  1. the patient information is not complete;
  2. the sample information is not complete;
  3. history of colorectal cancer surgery or other cancer history, or any chemotherapy;
  4. women in pregnancy;
  5. samples not comply with any of the above selection criteria

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): NCT02540850


Locations
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China
Beijing Cancer Hospital
Beijing, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
General Hospital of Beijing PLA Military Region
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Sponsors and Collaborators
BioChain (Beijing) Science and Technology, Inc.
Peking Union Medical College Hospital
General Hospital of Beijing PLA Military Region
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Cancer Hospital
Investigators
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Study Director: XIAOLIANG HAN, Ph.D. BioChain (Beijing) Science and Technology, Inc.
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Responsible Party: BioChain (Beijing) Science and Technology, Inc.
ClinicalTrials.gov Identifier: NCT02540850    
Other Study ID Numbers: RESEPT
First Posted: September 4, 2015    Key Record Dates
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016
Last Verified: January 2016
Keywords provided by BioChain (Beijing) Science and Technology, Inc.:
methylation
septin 9
SEPT9
colorectal cancer
CRC
screening
adenoma
polyps
FIT
FOBT
colonoscopy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenomatous Polyps
Polyps
Disease
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Intestinal Polyps