Colorectal CancerNCT01741363
Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing
A study testing FIT(Eiken OC-Sensor) Two-day sampling, FIT(Eiken OC-Sensor) One-year interval and FIT(Eiken OC-Sensor) One-day sampling in people with Colorectal Cancer and Stomach Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. The abundant results from this trial will be helpful for assessing the feasibility of increasing stool sampling and shortening screening interval in population setting for lower and upper gastrointestinal tract lesions, their long-term effects, and the respective cost-effectiveness. 2. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Stomach Disease
- What is being tested?
- FIT(Eiken OC-Sensor) Two-day sampling, FIT(Eiken OC-Sensor) One-year interval and FIT(Eiken OC-Sensor) One-day sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99,314 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2014to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 to 69 years average-risk subjects for FIT
- 50 to 69 years subjects for HpSA
Who cannot join
- Subjects who are unwilling to participate
- Subjects ineligible for colonoscopy (for the one-day vs two day FIT screening)
- Subjects with a history of total gastrectomy
- Pregnancy
- Subjects with severe illnesses
- Subjects with prior participation in the pilot program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing: a Population-based Randomized Study
- The abundant results from this trial will be helpful for assessing the feasibility of increasing stool sampling and shortening screening interval in population setting for lower and upper gastrointestinal tract lesions, their long-term effects, and the respective cost-effectiveness.
- The study will evaluate the value of population-based screen and treatment for H. pylori infection when the HPSA is combined with the FIT.
Read the detailed description
Growing body of evidences have shown that fecal immunochemical test (FIT) outperform guaiac fecal occult blood test (gFOBT) in terms of sensitivity, neoplasm detection rate and public participation. Though direct outcome evidence is still lacking for FIT, it is anticipated to have higher colorectal cancer (CRC) mortality and incidence reduction compared with gFOBT. In Taiwan, nation-wide CRC screening program has been launched since the year of 2004 ,which provides biennial FIT screening for adults aged 50 to 69 years. Currently available data from the Bureau of Health Promotion has shown a significant stage-shift effect, an early indicator of screening effectiveness, by this screening program.
Nevertheless, the aforementioned advantages of FIT, missed neoplasms and interval cancer still exists under the current one-day stool sampling method with biennial screening interval, which might affect the effectiveness of overall screening program. Increase the number of stool samples or shortening of screening interval may be helpful for early detection of clinically significant neoplasms but it remains unclear whether such an approach may lower the screenee compliance or public participation. Moreover, its impact on the demand of confirmatory colonoscopy and cost-effectiveness of the whole screening program is still largely unknown and need to be further investigated.
In this study, we firstly aim to randomly allocate screening attendee to one of the following four arms: one-day sampling with annual screening, one-day sampling with biennial screening, two-day sampling with annual screening, and two-day sampling with biennial screening. Participation rate, positive rates of FIT, detection rate for neoplasms, positive predictive value, and long-term outcome including cancer incidence and mortality will be calculated and compared among four groups.
Secondly, in the Taiwanese population, which is a typical presentation of Asian populations, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper gastrointestinal pathologies remain highly prevalent, which may imply that mass screening solely based on FIT could be insufficient as significant upper GI pathologies can be missed. Since the FIT does not predict upper GI pathologies, the adjunct of an「Helicobacter pylori stool-antigen test (HpSA) 」 may be a potential candidate to realize a pan-detecting assay based on stool samples in a population in which both lower and upper GI lesions are equally prevalent. Therefore, in the present study, we will also evaluate the value of simultaneous FIT and HpSA test in the community-based mass screening. We invited subjects in a randomized study to receive the FIT or the FIT plus HPSA. Those who are tested positive for HPSA will receive upper endoscopic examination and anti-H. pylori treatment. For the short-term indicators, we will evaluate the participation rate and diagnostic yield when the HPSA is added. For the long-term indicators, we will compare the incidence and mortality of gastric cancer as well as complicated peptic ulcers.
To summary, this study includes two randomized trials:
- To make a comparison between one-day sampling with annual screening, one-day sampling with biennial screening, two-day sampling with annual screening, and two-day sampling with biennial screening using FIT;
- To make a comparison between FIT plus HpSA and FIT alone for screening.
Finally, the cost-effectiveness analysis will be also conducted using previously established Markov model of CRC natural history and stomach diseases (such as dyspepsia, peptic ulcer disease, and gastric cancer) using the results ascertained from this trial. The primary outcomes were gastric cancer incidence and mortality rates as well as colorectal cancer incidence and mortality rates.
- Conditions
- Colorectal Cancer, Stomach Disease
- Being tested
- FIT(Eiken OC-Sensor) Two-day sampling, FIT(Eiken OC-Sensor) One-year interval, FIT(Eiken OC-Sensor) One-day sampling, FIT(Eiken OC-Sensor) Two-year interval, HpSA (Firstep Helicobacter pylori Antigen Rapid Test)
- Keywords
- iFOBT, one-day sample, two-day sample, Helicobacter pylori stool antigen
- Medical subject headings
- Colorectal Neoplasms, Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT(Eiken OC-Sensor) Two-day samplingOther
Collect two stool samples in two separate days
FIT(Eiken OC-Sensor) One-year intervalOther
Screening with one-year interval
FIT(Eiken OC-Sensor) One-day samplingOther
One-day sampling
FIT(Eiken OC-Sensor) Two-year intervalOther
Screening with two-year interval
HpSA (Firstep Helicobacter pylori Antigen Rapid Test)Other
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 onlyOther
HPSA+FIT compared with FIT alone.
| Study group | Role | What they receive |
|---|---|---|
| one-day sampling with one-year interval | Experimental | FIT one-day sampling with one-year interval Receives: Other: FIT(Eiken OC-Sensor) One-year interval; Other: FIT(Eiken OC-Sensor) One-day sampling |
| one-day sampling with two-year interval | Active comparator | FIT one-day sampling with two-year interval Receives: Other: FIT(Eiken OC-Sensor) One-day sampling; Other: FIT(Eiken OC-Sensor) Two-year interval |
| two-day sampling with one-year interval | Experimental | FIT two-day sampling with one-year interval Receives: Other: FIT(Eiken OC-Sensor) Two-day sampling; Other: FIT(Eiken OC-Sensor) One-year interval |
| two-day sampling with two-year interval | Experimental | FIT two-day sampling with two-year interval Receives: Other: FIT(Eiken OC-Sensor) Two-day sampling; Other: FIT(Eiken OC-Sensor) Two-year interval |
| Hp stool antigen (HpSA)+FIT | Experimental | HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT Receives: Other: FIT(Eiken OC-Sensor) One-day sampling; Other: FIT(Eiken OC-Sensor) Two-year interval; Other: HpSA (Firstep Helicobacter pylori Antigen Rapid Test) |
| FIT only | Active comparator | HpSA + FIT compared with FIT alone Receives: Other: FIT(Eiken OC-Sensor) One-day sampling; Other: FIT(Eiken OC-Sensor) Two-year interval; Other: FIT only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Stomach Cancer
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.
Measured: 5.5 years
Mortality of Stomach Cancer
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.
Measured: 5.5 years
Secondary outcomes (2)
Mortality of Colorectal Cancer
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.
Measured: 5.5 years
Incidence of Colorectal Cancer
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.
Measured: 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Han-Mo Chiu, M.D., Ph.D., Principal investigator, Department of Internal Medicine & Health Management CenterYi-Chia Lee, M.D., Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741363
- Sponsor's protocol ID
- 201205030RIB
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2012
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee YC, Liu JH, Mulder DT, Yang JY, Chiang TH, Hsu WF, Chiu HM, Su WW, Chou KC, Chen SL, Fann JC, Chiu SY, Chuang SL, Chen YR, Chu TC, Chang MY, Chen ST, Hu TH, Fang YJ, Liou JM, Wu MS, Yeh YP, Hur C, Yen AM, Chen TH; Collaborators of the Taiwan Community-Based Integrated Screening Group. Cost-Effectiveness of Fecal Immunochemical Testing Alone vs Co-Testing With Helicobacter pylori Stool Antigen. JAMA. 2026 Jul 7;336(1):35-46. doi: 10.1001/jama.2026.6908.
PubMed 42223961Lee YC, Chiang TH, Chiu HM, Su WW, Chou KC, Chen SL, Yen AM, Fann JC, Chiu SY, Chuang SL, Chen YR, Chen SD, Hu TH, Fang YJ, Wu MS, Chen TH, Yeh YP; Collaborators of Taiwan Community-based Integrated Screening Group. Screening for Helicobacter pylori to Prevent Gastric Cancer: A Pragmatic Randomized Clinical Trial. JAMA. 2024 Nov 19;332(19):1642-1651. doi: 10.1001/jama.2024.14887.
PubMed 39348147Lee YC, Chiang TH, Chiu HM, Wu MS, Yeh YP, Hsiu-Hsi Chen T; Collaborators of the Taiwan Community-Based Integrated Screening Group. Community-Based Gastric Cancer Screening Coupled With a National Colorectal Cancer Screening Program: Baseline Results. Gastroenterology. 2021 May;160(6):2159-2161.e4. doi: 10.1053/j.gastro.2021.01.008. Epub 2021 Jan 11. No abstract available.
PubMed 33444571
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing: a Population-based Randomized Study
- ClinicalTrials.gov ID
- NCT01741363
- Acronym / sponsor ID
- 201205030RIB
- Conditions
- Colorectal Cancer, Stomach Disease
- Keywords
- iFOBT, one-day sample, two-day sample, Helicobacter pylori stool antigen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99,314 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The abundant results from this trial will be helpful for assessing the feasibility of increasing stool sampling and shortening screening interval in population setting for lower and upper gastrointestinal tract lesions, their long-term effects, and the respective cost-effectiveness.
- The study will evaluate the value of population-based screen and treatment for H. pylori infection when the HPSA is combined with the FIT.
Detailed description
Growing body of evidences have shown that fecal immunochemical test (FIT) outperform guaiac fecal occult blood test (gFOBT) in terms of sensitivity, neoplasm detection rate and public participation. Though direct outcome evidence is still lacking for FIT, it is anticipated to have higher colorectal cancer (CRC) mortality and incidence reduction compared with gFOBT. In Taiwan, nation-wide CRC screening program has been launched since the year of 2004 ,which provides biennial FIT screening for adults aged 50 to 69 years. Currently available data from the Bureau of Health Promotion has shown a significant stage-shift effect, an early indicator of screening effectiveness, by this screening program.
Nevertheless, the aforementioned advantages of FIT, missed neoplasms and interval cancer still exists under the current one-day stool sampling method with biennial screening interval, which might affect the effectiveness of overall screening program. Increase the number of stool samples or shortening of screening interval may be helpful for early detection of clinically significant neoplasms but it remains unclear whether such an approach may lower the screenee compliance or public participation. Moreover, its impact on the demand of confirmatory colonoscopy and cost-effectiveness of the whole screening program is still largely unknown and need to be further investigated.
In this study, we firstly aim to randomly allocate screening attendee to one of the following four arms: one-day sampling with annual screening, one-day sampling with biennial screening, two-day sampling with annual screening, and two-day sampling with biennial screening. Participation rate, positive rates of FIT, detection rate for neoplasms, positive predictive value, and long-term outcome including cancer incidence and mortality will be calculated and compared among four groups.
Secondly, in the Taiwanese population, which is a typical presentation of Asian populations, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper gastrointestinal pathologies remain highly prevalent, which may imply that mass screening solely based on FIT could be insufficient as significant upper GI pathologies can be missed. Since the FIT does not predict upper GI pathologies, the adjunct of an「Helicobacter pylori stool-antigen test (HpSA) 」 may be a potential candidate to realize a pan-detecting assay based on stool samples in a population in which both lower and upper GI lesions are equally prevalent. Therefore, in the present study, we will also evaluate the value of simultaneous FIT and HpSA test in the community-based mass screening. We invited subjects in a randomized study to receive the FIT or the FIT plus HPSA. Those who are tested positive for HPSA will receive upper endoscopic examination and anti-H. pylori treatment. For the short-term indicators, we will evaluate the participation rate and diagnostic yield when the HPSA is added. For the long-term indicators, we will compare the incidence and mortality of gastric cancer as well as complicated peptic ulcers.
To summary, this study includes two randomized trials:
- To make a comparison between one-day sampling with annual screening, one-day sampling with biennial screening, two-day sampling with annual screening, and two-day sampling with biennial screening using FIT;
- To make a comparison between FIT plus HpSA and FIT alone for screening.
Finally, the cost-effectiveness analysis will be also conducted using previously established Markov model of CRC natural history and stomach diseases (such as dyspepsia, peptic ulcer disease, and gastric cancer) using the results ascertained from this trial. The primary outcomes were gastric cancer incidence and mortality rates as well as colorectal cancer incidence and mortality rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| one-day sampling with one-year interval | Experimental | Other: FIT(Eiken OC-Sensor) One-year interval, Other: FIT(Eiken OC-Sensor) One-day samplingFIT one-day sampling with one-year interval |
| one-day sampling with two-year interval | Active comparator | Other: FIT(Eiken OC-Sensor) One-day sampling, Other: FIT(Eiken OC-Sensor) Two-year intervalFIT one-day sampling with two-year interval |
| two-day sampling with one-year interval | Experimental | Other: FIT(Eiken OC-Sensor) Two-day sampling, Other: FIT(Eiken OC-Sensor) One-year intervalFIT two-day sampling with one-year interval |
| two-day sampling with two-year interval | Experimental | Other: FIT(Eiken OC-Sensor) Two-day sampling, Other: FIT(Eiken OC-Sensor) Two-year intervalFIT two-day sampling with two-year interval |
| Hp stool antigen (HpSA)+FIT | Experimental | Other: FIT(Eiken OC-Sensor) One-day sampling, Other: FIT(Eiken OC-Sensor) Two-year interval, Other: HpSA (Firstep Helicobacter pylori Antigen Rapid Test)HpSA for detection of upper gastrointestinal tract diseases and upper endoscopy for H. pylori carriers; HPSA combined with FIT |
| FIT only | Active comparator | Other: FIT(Eiken OC-Sensor) One-day sampling, Other: FIT(Eiken OC-Sensor) Two-year interval, Other: FIT onlyHpSA + FIT compared with FIT alone |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 to 69 years average-risk subjects for FIT
- 50 to 69 years subjects for HpSA
Key exclusion criteria (6 listed)
- Subjects who are unwilling to participate
- Subjects ineligible for colonoscopy (for the one-day vs two day FIT screening)
- Subjects with a history of total gastrectomy
- Pregnancy
- Subjects with severe illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT(Eiken OC-Sensor) Two-day samplingCollect two stool samples in two separate days | Other | two-day sampling with one-year interval, two-day sampling with two-year interval |
| FIT(Eiken OC-Sensor) One-year intervalScreening with one-year interval | Other | one-day sampling with one-year interval, two-day sampling with one-year interval |
| FIT(Eiken OC-Sensor) One-day samplingOne-day sampling | Other | FIT only, Hp stool antigen (HpSA)+FIT, one-day sampling with one-year interval, one-day sampling with two-year interval |
| FIT(Eiken OC-Sensor) Two-year intervalScreening with two-year interval | Other | FIT only, Hp stool antigen (HpSA)+FIT, one-day sampling with two-year interval, two-day sampling 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. | Other | Hp stool antigen (HpSA)+FIT |
| FIT onlyHPSA+FIT compared with FIT alone. | Other | FIT only |
Primary outcome
Incidence of Stomach Cancer
Time frame: 5.5 years
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.
Mortality of Stomach Cancer
Time frame: 5.5 years
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.
2 secondary outcomes
Mortality of Colorectal Cancer
Time frame: 5.5 years
Incidence of Colorectal Cancer
Time frame: 5.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42223961Lee YC, Liu JH, Mulder DT, Yang JY, Chiang TH, Hsu WF, Chiu HM, Su WW, Chou KC, Chen SL, Fann JC, Chiu SY, Chuang SL, Chen YR, Chu TC, Chang MY, Chen ST, Hu TH, Fang YJ, Liou JM, Wu MS, Yeh YP, Hur C, Yen AM, Chen TH; Collaborators of the Taiwan Community-Based Integrated Screening Group. Cost-Effectiveness of Fecal Immunochemical Testing Alone vs Co-Testing With Helicobacter pylori Stool Antigen. JAMA. 2026 Jul 7;336(1):35-46. doi: 10.1001/jama.2026.6908.
- Derived from this study: PubMed 39348147Lee YC, Chiang TH, Chiu HM, Su WW, Chou KC, Chen SL, Yen AM, Fann JC, Chiu SY, Chuang SL, Chen YR, Chen SD, Hu TH, Fang YJ, Wu MS, Chen TH, Yeh YP; Collaborators of Taiwan Community-based Integrated Screening Group. Screening for Helicobacter pylori to Prevent Gastric Cancer: A Pragmatic Randomized Clinical Trial. JAMA. 2024 Nov 19;332(19):1642-1651. doi: 10.1001/jama.2024.14887.
- Derived from this study: PubMed 33444571Lee YC, Chiang TH, Chiu HM, Wu MS, Yeh YP, Hsiu-Hsi Chen T; Collaborators of the Taiwan Community-Based Integrated Screening Group. Community-Based Gastric Cancer Screening Coupled With a National Colorectal Cancer Screening Program: Baseline Results. Gastroenterology. 2021 May;160(6):2159-2161.e4. doi: 10.1053/j.gastro.2021.01.008. Epub 2021 Jan 11. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Mo Chiu, M.D., Ph.D. principal investigator
Department of Internal Medicine & Health Management Center
Yi-Chia Lee, M.D., Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT(Eiken OC-Sensor) Two-day sampling, FIT(Eiken OC-Sensor) One-year interval and FIT(Eiken OC-Sensor) One-day sampling in people with Colorectal Cancer and Stomach Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Stomach Cancer (time frame: 5.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01741363, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.