Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Colorectal Cancer
Adenomatous Polyp of Colon
Polyps
Other Disease/Injury
Other Cancers
Enrollment 1031
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description stage 0-IV CRC subjects subjects with adenoma or polyps subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Period Title: Overall Study
Started 360 396 444
Completed 291 330 410
Not Completed 69 66 34
Reason Not Completed
Lost to Follow-up             69             66             34
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group Total
Hide Arm/Group Description stage 0-IV CRC subjects subjects with adenoma or polyps subjects with other bowel diseases, other cancers, and subjects with no evidence of disease Total of all reporting groups
Overall Number of Baseline Participants 291 330 410 1031
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 330 participants 410 participants 1031 participants
<=18 years
0
   0.0%
0
   0.0%
1
   0.2%
1
   0.1%
Between 18 and 65 years
188
  64.6%
265
  80.3%
390
  95.1%
843
  81.8%
>=65 years
103
  35.4%
65
  19.7%
19
   4.6%
187
  18.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 291 participants 330 participants 410 participants 1031 participants
59.5
(25 to 88)
54.7
(24 to 85)
48.4
(17 to 82)
53.5
(17 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 330 participants 410 participants 1031 participants
Female
108
  37.1%
144
  43.6%
234
  57.1%
486
  47.1%
Male
183
  62.9%
186
  56.4%
176
  42.9%
545
  52.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 291 participants 330 participants 410 participants 1031 participants
291 330 410 1031
1.Primary Outcome
Title Ct Value (Ct Values From PCR Reaction)
Hide Description the number of PCR cycles where the amplification signal starts to be observed
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description:
stage 0-IV CRC subjects
subjects with adenoma or polyps
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Overall Number of Participants Analyzed 291 330 410
Mean (95% Confidence Interval)
Unit of Measure: Ct
38.4
(37.8 to 38.9)
44.3
(44.1 to 44.5)
44.6
(44.4 to 44.7)
2.Secondary Outcome
Title Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer)
Hide Description the ratio of positive cases in all CRC cases
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description:
stage 0-IV CRC subjects
subjects with adenoma or polyps
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Overall Number of Participants Analyzed 291 330 410
Measure Type: Number
Unit of Measure: Percentage of positives in disease group
76.6 8.2 0
3.Secondary Outcome
Title Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases))
Hide Description the ratio of negative cases in all non-CRC or NED cases
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description:
stage 0-IV CRC subjects
subjects with adenoma or polyps
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Overall Number of Participants Analyzed 291 330 410
Measure Type: Number
Unit of Measure: percentage of true negs in non-CRC group
0 0 95.9
4.Secondary Outcome
Title PPV (the Positive Predictive Value of mSEPT9 Assay in the Population)
Hide Description the ratio of true positive in all positive cases
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description:
stage 0-IV CRC subjects
subjects with adenoma or polyps
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Overall Number of Participants Analyzed 291 330 410
Measure Type: Number
Unit of Measure: percentage of true pos in all pos cases
83.8 0 0
5.Secondary Outcome
Title NPV (the Negative Predictive Value of mSEPT9 Assay in the Population)
Hide Description the ratio of true negative in all negative cases
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description:
stage 0-IV CRC subjects
subjects with adenoma or polyps
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Overall Number of Participants Analyzed 291 330 410
Measure Type: Number
Unit of Measure: percentage of true negs in all neg cases
0 0 91.1
6.Secondary Outcome
Title Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population)
Hide Description the ratio of positive cases in all cases
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description:
stage 0-IV CRC subjects
subjects with adenoma or polyps
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Overall Number of Participants Analyzed 291 330 410
Measure Type: Number
Unit of Measure: percentage of positives in each group
76.6 8.2 3.9
7.Secondary Outcome
Title Consistency (the Overall Ratio of True Positive and True Negative)
Hide Description The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description:
stage 0-IV CRC subjects
subjects with adenoma or polyps
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
Overall Number of Participants Analyzed 291 330 410
Measure Type: Number
Unit of Measure: percentage of true pos&negs in all cases
89.2 89.2 89.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CRC Group Precancerous Disease Group Other Disease Group
Hide Arm/Group Description stage 0-IV CRC subjects subjects with adenoma or polyps subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
All-Cause Mortality
CRC Group Precancerous Disease Group Other Disease Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CRC Group Precancerous Disease Group Other Disease Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/291 (0.00%)   0/330 (0.00%)   0/410 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CRC Group Precancerous Disease Group Other Disease Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/291 (0.00%)   0/330 (0.00%)   0/410 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Agreement between the sponsor and the clinical hospitals was signed and will be valid if no parties propose to change the agreement, the detailed trial data will not be made public until the trial data is published by the sponsor and/or the hospitals.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lele Song
Organization: BioChain (Beijing) Science and Technology, Inc.
Phone: 86-10-63401580
EMail: songlele@biochainbj.com
Layout table for additonal information
Responsible Party: BioChain (Beijing) Science and Technology, Inc.
ClinicalTrials.gov Identifier: NCT02540850    
Other Study ID Numbers: RESEPT
First Submitted: August 12, 2015
First Posted: September 4, 2015
Results First Submitted: October 13, 2015
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016