Trial Outcomes & Findings for Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing (NCT NCT01741363)

Results Overview

Number of incident stomach cancer The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99314 participants

Primary outcome timeframe

5.5 years

Results posted on

2024-11-21

Participant Flow

2014/04/01 First patient first visit

2018/09/27 Last patient last visit

Participant milestones

Participant milestones
Measure	One-day Sampling With One-year Interval FIT one-day sampling with one-year interval FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval FIT(Eiken OC-Sensor) One-day sampling: One-day sampling	Two-day Sampling With One-year Interval FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	One-day Sampling With Two-year Interval FIT one-day sampling with two-year interval FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Two-day Sampling With Two-year Interval FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA)+FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Overall Study STARTED	9076	8987	9032	8945	31497	31777
Overall Study COMPLETED	9076	8987	9032	8945	31497	31777
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One-day Sampling With One-year Interval n=9076 Participants FIT one-day sampling with one-year interval FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval FIT(Eiken OC-Sensor) One-day sampling: One-day sampling	One-day Sampling With Two-year Interval n=8987 Participants FIT one-day sampling with two-year interval FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Two-day Sampling With One-year Interval n=9032 Participants FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval n=8945 Participants FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA)+FIT n=31497 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=31777 Participants HPSA+FIT compared with FIT alone.	Total n=99314 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	7248 Participants n=5 Participants	7492 Participants n=7 Participants	7220 Participants n=5 Participants	7474 Participants n=4 Participants	25393 Participants n=21 Participants	25556 Participants n=8 Participants	80383 Participants n=8 Participants
Age, Categorical >=65 years	1828 Participants n=5 Participants	1495 Participants n=7 Participants	1812 Participants n=5 Participants	1471 Participants n=4 Participants	6104 Participants n=21 Participants	6221 Participants n=8 Participants	18931 Participants n=8 Participants
Sex: Female, Male Female	5206 Participants n=5 Participants	4941 Participants n=7 Participants	5124 Participants n=5 Participants	4990 Participants n=4 Participants	18473 Participants n=21 Participants	18523 Participants n=8 Participants	57257 Participants n=8 Participants
Sex: Female, Male Male	3870 Participants n=5 Participants	4046 Participants n=7 Participants	3908 Participants n=5 Participants	3955 Participants n=4 Participants	13024 Participants n=21 Participants	13254 Participants n=8 Participants	42057 Participants n=8 Participants
Race/Ethnicity, Customized Asian	9076 Participants n=5 Participants	8987 Participants n=7 Participants	9032 Participants n=5 Participants	8945 Participants n=4 Participants	31497 Participants n=21 Participants	31777 Participants n=8 Participants	99314 Participants n=8 Participants
Gastric cancer and colorectal cancer incidence/mortality	9076 Participants n=5 Participants	8987 Participants n=7 Participants	9032 Participants n=5 Participants	8945 Participants n=4 Participants	31497 Participants n=21 Participants	31777 Participants n=8 Participants	99314 Participants n=8 Participants

PRIMARY outcome

Timeframe: 5.5 years

Population: Average risk population

Number of incident stomach cancer The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=31497 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=31777 Participants HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Incidence of Stomach Cancer	49 Participants	59 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 5.5 years

Population: Average risk population

Number of stomach cancer death The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=31497 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=31777 Participants HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Mortality of Stomach Cancer	17 Participants	23 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 5.5 years

Population: Average risk population

Number of colorectal cancer death The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=9076 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=8987 Participants HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval n=9032 Participants FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval n=8945 Participants FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Mortality of Colorectal Cancer	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 5.5 years

Population: Average risk population

Number of incident colorectal cancer The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=9076 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=8987 Participants HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval n=9032 Participants FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval n=8945 Participants FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Incidence of Colorectal Cancer	0 Participants	0 Participants	0 Participants	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5.5 years

Population: subjects with HpSA positive test

Subjects who received anti-H. pylori treatment. The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=12142 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Helicobacter Pylori Eradication Rate	8809 Participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5.5 years

Population: subjects with positive stool test

Subjects who received confirmatory examinations (colonoscopy or flexible sigmoidoscopy plus double contrast barium enema for lower gastrointestinal tract disease; esophagogastroduodenoscopy for upper gastrointestinal tract disease) /subjects with positive stool test (FIT or HpSA) The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=486 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=712 Participants HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval n=506 Participants FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval n=719 Participants FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT n=2230 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=2214 Participants HPSA+FIT compared with FIT alone.
Confirmatory Examination Referral Rate	328 Participants	473 Participants	355 Participants	493 Participants	1724 Participants	1739 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5.5 years

Number of Advanced Adenoma and Colorectal Cancer The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=9076 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=8987 Participants HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval n=9032 Participants FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval n=8945 Participants FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Detection of Advanced Adenoma and Cancer	0 Participants	0 Participants	0 Participants	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5.5 years

Population: Average risk population

Number of participants from invitation population The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.

Outcome measures

Outcome measures
Measure	Hp Stool Antigen (HpSA)+FIT n=63508 Participants HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only n=88995 Participants HpSA + FIT compared with FIT alone FIT(Eiken OC-Sensor) One-day sampling: One-day sampling FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval FIT only: HPSA+FIT compared with FIT alone.	Two-day Sampling With One-year Interval FIT two-day sampling with one-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) One-year interval: Screening with one-year interval	Two-day Sampling With Two-year Interval FIT two-day sampling with two-year interval FIT(Eiken OC-Sensor) Two-day sampling: Collect two stool samples in two separate days FIT(Eiken OC-Sensor) Two-year interval: Screening with two-year interval	Hp Stool Antigen (HpSA) + FIT HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT HpSA (Firstep Helicobacter pylori Antigen Rapid Test): HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.	FIT Only HPSA+FIT compared with FIT alone.
Participation Rate of HpSA + FIT or FIT Only	31497 Participants	31777 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5.5 years

Population: Average risk population

Number of non-advanced adenoma from study population The recruitment period of participants was from January 1, 2014 to September 27, 2018. Final follow-up occurred December 31, 2020. For outcome measurement, the average follow-up time of the study participants was 5.5 years.