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| Name | Class |
|---|---|
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one-day sampling with one-year interval | Experimental | FIT one-day sampling with one-year interval |
|
| one-day sampling with two-year interval | Active Comparator | FIT one-day sampling with two-year interval |
|
| two-day sampling with one-year interval | Experimental | FIT two-day sampling with one-year interval |
|
| two-day sampling with two-year interval | Experimental | FIT two-day sampling with 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIT(Eiken OC-Sensor) Two-day sampling | Other | Collect two stool samples in two separate days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 5.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5.5 years |
| Incidence of Colorectal Cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter Pylori Eradication Rate | 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. | 5.5 years |
Inclusion Criteria:
Exclusion Criteria (for the FIT-based RCT):
Exclusion Criteria (for the FIT+HPSA vs. FIT-only RCT)
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| Name | Affiliation | Role |
|---|---|---|
| Han-Mo Chiu, M.D., Ph.D. | Department of Internal Medicine & Health Management Center | Principal Investigator |
| Yi-Chia Lee, M.D., Ph.D. | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42223961 | Derived | 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 Jun 1:e266908. doi: 10.1001/jama.2026.6908. Online ahead of print. | |
| 39348147 |
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2018/09/27 Last patient last visit
2014/04/01 First patient first visit
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Two-day Sampling With One-year Interval |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2012 | Aug 29, 2017 |
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| FIT only | Active Comparator | HpSA + FIT compared with FIT alone |
|
| FIT(Eiken OC-Sensor) One-year interval | Other | Screening with one-year interval |
|
| FIT(Eiken OC-Sensor) One-day sampling | Other | One-day sampling |
|
| FIT(Eiken OC-Sensor) Two-year interval | Other | 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 only | Other | HPSA+FIT compared with FIT alone. |
|
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. |
| 5.5 years |
| Confirmatory Examination Referral Rate |
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. |
| 5.5 years |
| Detection of Advanced Adenoma and Cancer | 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. | 5.5 years |
| Participation Rate of HpSA + FIT or FIT Only | 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. | 5.5 years |
| Detection of Non-advanced Adenoma | 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. | 5.5 years |
| Derived |
| Lee 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. |
| 33444571 | Derived | Lee 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. |
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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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. |
| FG005 | FIT Only | HPSA+FIT compared with FIT alone. |
| COMPLETED |
|
| NOT COMPLETED |
|
Average risk population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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. |
| BG005 | FIT Only | HPSA+FIT compared with FIT alone. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Gastric cancer and colorectal cancer incidence/mortality | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Average risk population | Posted | Count of Participants | Participants | 5.5 years |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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. | Average risk population | Posted | Count of Participants | Participants | 5.5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Average risk population | Posted | Count of Participants | Participants | 5.5 years |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Average risk population | Posted | Count of Participants | Participants | 5.5 years |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Helicobacter Pylori Eradication Rate | 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. | subjects with HpSA positive test | Posted | Count of Participants | Participants | 5.5 years |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Confirmatory Examination Referral Rate | 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. | subjects with positive stool test | Posted | Count of Participants | Participants | 5.5 years |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Detection of Advanced Adenoma and Cancer | 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. | Posted | Count of Participants | Participants | 5.5 years |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Participation Rate of HpSA + FIT or FIT Only | 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. | Average risk population | Posted | Count of Participants | Participants | 5.5 years |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Detection of Non-advanced Adenoma | 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. | Average risk population | Posted | Count of Participants | Participants | 5.5 years |
|
5.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 9,076 | 0 | 9,076 | 0 | 9,076 |
| EG001 | 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 | 0 | 8,987 | 0 | 8,987 | 0 | 8,987 |
| EG002 | 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 | 0 | 9,032 | 0 | 9,032 | 0 | 9,032 |
| EG003 | 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 | 0 | 8,945 | 0 | 8,945 | 0 | 8,945 |
| EG004 | 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. | 34 | 31,497 | 0 | 31,497 | 0 | 31,497 |
| EG005 | FIT Only | HPSA+FIT compared with FIT alone. | 37 | 31,777 | 0 | 31,777 | 0 | 31,777 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Han-Mo CHIU | Department of Internal Medicine, National Taiwan University Hospita | +886-2-23123456 | 63354 | hanmochiu@ntu.edu.tw |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2012 | Aug 29, 2017 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2013 | Aug 31, 2017 | ICF_002.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Participants |
|
|
| 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 |
|
|
| OG003 |
| 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 |
|
|
|
| OG003 | 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 |
| OG004 | 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. |
| OG005 | FIT Only | HPSA+FIT compared with FIT alone. |
|
|
| 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 |
|
|
| Counts |
|---|
| Participants |
|
|
| OG003 |
| 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 |
|
|