Trial Outcomes & Findings for CRC Screening Using mSEPT9 (Methylated Septin 9) in Chinese Population (NCT NCT02540850)
NCT ID: NCT02540850
Last Updated: 2016-01-11
Results Overview
the number of PCR cycles where the amplification signal starts to be observed
Recruitment status
COMPLETED
Target enrollment
1031 participants
Primary outcome timeframe
1 year
Results posted on
2016-01-11
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
360
|
396
|
444
|
|
Overall Study
COMPLETED
|
291
|
330
|
410
|
|
Overall Study
NOT COMPLETED
|
69
|
66
|
34
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
69
|
66
|
34
|
Baseline Characteristics
CRC Screening Using mSEPT9 (Methylated Septin 9) in Chinese Population
Baseline characteristics by cohort
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
Total
n=1031 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
188 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
843 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
103 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
54.7 years
n=7 Participants
|
48.4 years
n=5 Participants
|
53.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
486 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
545 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
291 participants
n=5 Participants
|
330 participants
n=7 Participants
|
410 participants
n=5 Participants
|
1031 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearthe number of PCR cycles where the amplification signal starts to be observed
Outcome measures
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
|---|---|---|---|
|
Ct Value (Ct Values From PCR Reaction)
|
38.4 Ct
Interval 37.8 to 38.9
|
44.3 Ct
Interval 44.1 to 44.5
|
44.6 Ct
Interval 44.4 to 44.7
|
SECONDARY outcome
Timeframe: 1 yearthe ratio of positive cases in all CRC cases
Outcome measures
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
|---|---|---|---|
|
Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer)
|
76.6 Percentage of positives in disease group
|
8.2 Percentage of positives in disease group
|
0 Percentage of positives in disease group
|
SECONDARY outcome
Timeframe: 1 yearthe ratio of negative cases in all non-CRC or NED cases
Outcome measures
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
|---|---|---|---|
|
Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases))
|
0 percentage of true negs in non-CRC group
|
0 percentage of true negs in non-CRC group
|
95.9 percentage of true negs in non-CRC group
|
SECONDARY outcome
Timeframe: 1 yearthe ratio of true positive in all positive cases
Outcome measures
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
|---|---|---|---|
|
PPV (the Positive Predictive Value of mSEPT9 Assay in the Population)
|
83.8 percentage of true pos in all pos cases
|
0 percentage of true pos in all pos cases
|
0 percentage of true pos in all pos cases
|
SECONDARY outcome
Timeframe: 1 yearthe ratio of true negative in all negative cases
Outcome measures
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
|---|---|---|---|
|
NPV (the Negative Predictive Value of mSEPT9 Assay in the Population)
|
0 percentage of true negs in all neg cases
|
0 percentage of true negs in all neg cases
|
91.1 percentage of true negs in all neg cases
|
SECONDARY outcome
Timeframe: 1 yearthe ratio of positive cases in all cases
Outcome measures
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
|---|---|---|---|
|
Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population)
|
76.6 percentage of positives in each group
|
8.2 percentage of positives in each group
|
3.9 percentage of positives in each group
|
SECONDARY outcome
Timeframe: 1 yearThe overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases
Outcome measures
| Measure |
CRC Group
n=291 Participants
stage 0-IV CRC subjects
|
Precancerous Disease Group
n=330 Participants
subjects with adenoma or polyps
|
Other Disease Group
n=410 Participants
subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
|
|---|---|---|---|
|
Consistency (the Overall Ratio of True Positive and True Negative)
|
89.2 percentage of true pos&negs in all cases
|
89.2 percentage of true pos&negs in all cases
|
89.2 percentage of true pos&negs in all cases
|
Adverse Events
CRC Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Precancerous Disease Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other Disease Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lele Song
BioChain (Beijing) Science and Technology, Inc.
Phone: 86-10-63401580
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER