Advanced Colorectal NeoplasmsNCT01341197
Fecal Screening Assay for Taiwanese Population
An observational study of Advanced Colorectal Neoplasms and Throat Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with human globin, a protein that is digested by upper GI… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Colorectal Neoplasms, Throat Cancer, Esophageal Cancer
- What is being tested?
- Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test
- How many people
- 3,172 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our study will enroll consecutive subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center), who will undergo a standard protocol, including I-FOBT, G-FOBT, HpSA, face-to-face interviews, blood chemistries, colonoscopy and EGD. Prior to the examination, a self-administered questionnaire will be used to collect information on participants' demographics, social habits, clinical symptoms, and medical/medication histories. To ensure that our study population was asymptomatic and the bleeders were occult, we excluded those who had overt GI symptoms and overt GI bleeding from analyses. During the same period, patients with screening detected GI tract cancers from other screening sites, such as throat cancer, esophageal cancer, gastric cancer, and colorectal cancers, will also be invited to participated in the study. This enrollment was based on insufficient GI cancer case number in the interim analyses based on a single screening site.
Who may be able to join
- subjects who received three fecal tests and receive confirmatory endoscopic diagnosis
Who cannot join
- subjects who had overt gastrointestinal bleeding (e.g., hematemesis, tarry stool, melena, and hematochezia) that would normally push the patients to seek immediate health care instead of participating in screening programs.
- subjects who do not receive the fecal tests
- subjects who do not receive the confirmatory endoscopic diagnosis
- subjects who had undergone gastrectomy or colectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pan-detecting Assay Based on Stool Samples for Taiwanese Population
Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with human globin, a protein that is digested by upper GI enzymes and is specific for detecting lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which may imply that mass screening solely based on I-FOBT could be insufficient as significant upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the adjuncts of G-FOBT and H. 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.
Read the detailed description
Background and objective: Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with human globin, a protein that is digested by upper GI enzymes and is specific for detecting lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which may imply that mass screening solely based on I-FOBT could be insufficient as significant upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the adjuncts of G-FOBT and H. 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.
Patients: Our study will enroll consecutive subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center), who will undergo I-FOBT, G-FOBT, HpSA, colonoscopy and EGD. The diagnostic values of three fecal testing, alone or in combination, will be respectively evaluated. knowing that subjects who were detected with gastrointestinal tract cancers might be small based on one screening setting, we also recruited patients who were detected with gastrointestinal tract cancers at other screening sites and were referred to the National Taiwan University Hospital for confirmatory diagnosis and treatment. They were also requested to complete the three fecal tests as well as the bidirectional endoscopies; however, it should be noted that, in this group of patients, those who completed only one of the bidirectional endoscopies were still eligible.
Our primary hypothesis was to test whether a guaiac-based test combined with an immunochemical test could help differentiate occult bleeding in the upper gastrointestinal tract from that in the lower gastrointestinal tract. As such a hypothesis would not be held, we also evaluated an alternative choice based on Helicobacter pylori stool antigen test to catching the upper gastrointestinal tract lesions.
- Conditions
- Advanced Colorectal Neoplasms, Throat Cancer, Esophageal Cancer, Gastric Cancer, Important Lower and Upper Gastrointestinal Tract Lesions
- Being tested
- Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test
- Keywords
- Fecal immunochemical test, Guaiac fecal occult blood test, Helicobacter pylori stool antigen test, Mass screening, Bidirectional endoscopy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen testOther
Also called Fecal immunochemical test: OC-SENSOR; Eiken Chemical Co., Ltd, Tokyo, Japan, Guaiac fecal occult-blood test: Hemoccult SENSA Single Slides, Beckman Coulter Inc., USA, Helicobacter pylori stool antigen test: Easy One Step Test, Firstep Bioresearch, Inc., Taiwan
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing bidirectional endoscopy and fecal tests | Subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center) Receives: Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test | |
| Patients with screening detected GI tract cancers | Patients with screening detected GI tract cancer, such as throat cancer, esophageal cancer, gastric cancer and colorectal cancers, from other screening sites in Taiwan and were referred to the National Taiwan University Hospital for confirmatory diagnosis and treatment. Receives: Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Important Lower and Upper GI tract Lesions
We define significant lower GI lesions as mass lesions (carcinoma and advanced adenoma), inflammation (erosive esophagitis, ulcer, and colitis), and vascular disorders (vascular ectasia and varices). Hyperplastic polyps are not considered significant lesions. Important upper GI lesions include cancer, esophageal varix, ulcer at least 0.5 cm in diameter with a perceptible depth, and angiodysplasia. Biopsies will be performed over any suspicious lesions for pathological confirmation. Reflux esophagitis with Los Angeles grade A or B severity is not considered significant.
Measured: On the day of receving endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Colorectal NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Chia Lee, MD.PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341197
- Sponsor's protocol ID
- 201101016RC
- Status last verified
- Nov 2012
- First submitted
- 21 Apr 2011
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee YC, Chiu HM, Chiang TH, Yen AM, Chiu SY, Chen SL, Fann JC, Yeh YP, Liao CS, Hu TH, Tu CH, Tseng PH, Chen CC, Chen MJ, Liou JM, Liao WC, Lai YP, Wang CP, Ko JY, Wang HP, Chiang H, Lin JT, Chen HH, Wu MS. Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions. BMJ Open. 2013 Oct 30;3(10):e003989. doi: 10.1136/bmjopen-2013-003989.
PubMed 24176798
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pan-detecting Assay Based on Stool Samples for Taiwanese Population
- ClinicalTrials.gov ID
- NCT01341197
- Acronym / sponsor ID
- 201101016RC
- Conditions
- Advanced Colorectal Neoplasms, Throat Cancer, Esophageal Cancer, Gastric Cancer, Important Lower and Upper Gastrointestinal Tract Lesions
- Keywords
- Fecal immunochemical test, Guaiac fecal occult blood test, Helicobacter pylori stool antigen test, Mass screening, Bidirectional endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,172 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with human globin, a protein that is digested by upper GI enzymes and is specific for detecting lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which may imply that mass screening solely based on I-FOBT could be insufficient as significant upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the adjuncts of G-FOBT and H. 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.
Detailed description
Background and objective: Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with human globin, a protein that is digested by upper GI enzymes and is specific for detecting lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which may imply that mass screening solely based on I-FOBT could be insufficient as significant upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the adjuncts of G-FOBT and H. 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.
Patients: Our study will enroll consecutive subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center), who will undergo I-FOBT, G-FOBT, HpSA, colonoscopy and EGD. The diagnostic values of three fecal testing, alone or in combination, will be respectively evaluated. knowing that subjects who were detected with gastrointestinal tract cancers might be small based on one screening setting, we also recruited patients who were detected with gastrointestinal tract cancers at other screening sites and were referred to the National Taiwan University Hospital for confirmatory diagnosis and treatment. They were also requested to complete the three fecal tests as well as the bidirectional endoscopies; however, it should be noted that, in this group of patients, those who completed only one of the bidirectional endoscopies were still eligible.
Our primary hypothesis was to test whether a guaiac-based test combined with an immunochemical test could help differentiate occult bleeding in the upper gastrointestinal tract from that in the lower gastrointestinal tract. As such a hypothesis would not be held, we also evaluated an alternative choice based on Helicobacter pylori stool antigen test to catching the upper gastrointestinal tract lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing bidirectional endoscopy and fecal tests | – | Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen testSubjects participating in the health check-up at National Taiwan University Hospital (Health Management Center) |
| Patients with screening detected GI tract cancers | – | Other: Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen testPatients with screening detected GI tract cancer, such as throat cancer, esophageal cancer, gastric cancer and colorectal cancers, from other screening sites in Taiwan and were referred to the National Taiwan University Hospital for confirmatory diagnosis and treatment. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our study will enroll consecutive subjects participating in the health check-up at National Taiwan University Hospital (Health Management Center), who will undergo a standard protocol, including I-FOBT, G-FOBT, HpSA, face-to-face interviews, blood chemistries, colonoscopy and EGD. Prior to the examination, a self-administered questionnaire will be used to collect information on participants' demographics, social habits, clinical symptoms, and medical/medication histories. To ensure that our study population was asymptomatic and the bleeders were occult, we excluded those who had overt GI symptoms and overt GI bleeding from analyses. During the same period, patients with screening detected GI tract cancers from other screening sites, such as throat cancer, esophageal cancer, gastric cancer, and colorectal cancers, will also be invited to participated in the study. This enrollment was based on insufficient GI cancer case number in the interim analyses based on a single screening site.
Key inclusion criteria (1 listed)
- subjects who received three fecal tests and receive confirmatory endoscopic diagnosis
Key exclusion criteria (4 listed)
- subjects who had overt gastrointestinal bleeding (e.g., hematemesis, tarry stool, melena, and hematochezia) that would normally push the patients to seek immediate health care instead of participating in screening programs.
- subjects who do not receive the fecal tests
- subjects who do not receive the confirmatory endoscopic diagnosis
- subjects who had undergone gastrectomy or colectomy
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 |
|---|---|---|
| Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen testAlso: Fecal immunochemical test: OC-SENSOR; Eiken Chemical Co., Ltd, Tokyo, Japan, Guaiac fecal occult-blood test: Hemoccult SENSA Single Slides, Beckman Coulter Inc., USA, Helicobacter pylori stool antigen test: Easy One Step Test, Firstep Bioresearch, Inc., Taiwan | Other | Patients with screening detected GI tract cancers, Subjects undergoing bidirectional endoscopy and fecal tests |
Primary outcome
Important Lower and Upper GI tract Lesions
Time frame: On the day of receving endoscopy
We define significant lower GI lesions as mass lesions (carcinoma and advanced adenoma), inflammation (erosive esophagitis, ulcer, and colitis), and vascular disorders (vascular ectasia and varices). Hyperplastic polyps are not considered significant lesions. Important upper GI lesions include cancer, esophageal varix, ulcer at least 0.5 cm in diameter with a perceptible depth, and angiodysplasia. Biopsies will be performed over any suspicious lesions for pathological confirmation. Reflux esophagitis with Los Angeles grade A or B severity is not considered significant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
- Derived from this study: PubMed 24176798Lee YC, Chiu HM, Chiang TH, Yen AM, Chiu SY, Chen SL, Fann JC, Yeh YP, Liao CS, Hu TH, Tu CH, Tseng PH, Chen CC, Chen MJ, Liou JM, Liao WC, Lai YP, Wang CP, Ko JY, Wang HP, Chiang H, Lin JT, Chen HH, Wu MS. Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions. BMJ Open. 2013 Oct 30;3(10):e003989. doi: 10.1136/bmjopen-2013-003989.
Related trials for Advanced Colorectal Neoplasms
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Yi-Chia Lee, MD.PhD 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?
An observational study of Advanced Colorectal Neoplasms and Throat Cancer, 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 1 inclusion and 4 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 3 Dec 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Important Lower and Upper GI tract Lesions (time frame: On the day of receving endoscopy). 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 NCT01341197, which also lists 1 linked publication.
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 3 Dec 2012.