Introduction

Romania has started in 2020 four regional EU-funded pilot programs for colorectal cancer (CRC) screening (ROCCAS projects). The program was developed with FIT as first tool of screening, followed by a colonoscopy invitation for FIT positive cases. By the end of December 2023 a cohort of 200.000 individuals is supposed to be tested with FIT (50.000 from each region).

Aims & Methods

Three out of four involved regions were screened using OC Sensor^TM as FIT (South-Muntenia, Bucharest-Ilfov, South-East). Persons aged between 50-74 years were invited to participate to the screening program. Initially, they completed a risk-assessment survey in order to stratify the cohort into two subgroups: average and high risk for CRC. This survey was conducted by the family doctor which then provided FIT for persons with average risk. Individuals belonging to the high risk group were directly invited to perform a colonoscopy. A FIT cut-off of 20 μg Hb/g feces was chosen and a colonoscopy was proposed to positive patients. The following quality parameters for FIT screening were evaluated: FIT return rate and colonoscopy acceptance rate according to age category, sex, and region of provenience. Data were retrieved from the ROCCAS national electronic register, managed by the Romanian National Public Health Institute.

Results

Between January 2022 and March 2023 a number of 79860 FIT were offered. A total of 70989 FIT were returned (preliminary return rate 88.8%). The overall return rate was similar between males (87.17%) and females (89.94%) independently from the region of origin and similarly distributed in the two considered age categories (Age<65= 88.22%; Age≥65=89.9%).
At the moment of data analysis the laboratory results were available for 70008 FIT: 5.61% positive FIT and 2.13% inconclusive, the rest 92.26% being negative. No difference in FIT positivity was observed among the three regions, while inconclusive tests were 2.67% and 2.31% in Bucharest Ilfov and South Muntenia respectively, the Sud-East region reported only 1%. The initial acceptability rate for colonoscopy was 52.3 %, however patients have a 6 month delay in which they can decide to undergo the procedure. Obviously, there is a delay between FIT processing, colonoscopy scheduling and data processing that needs to be taken into consideration.

Conclusion

In these preliminary results there was a high return rate when compared to other EU country reports. We consider that the high return rate is due to the direct involvement of the family doctors and probably it will diminish with the roll-out national extension. The FIT positivity interval between 5 and 6 % during this entire period was considered acceptable and the FIT cut-off was maintained. Our preliminary data are within EU recommended quality parameters and create beneficial premises for the expansion into the future national screening program beyond 2024. On the other hand, we need to make important efforts in order to increase the colonoscopy acceptance rate.

References

[1] Against Cancer, Cancer Screening in the European Union (2017) - Report on the implementation of the Council Recommendation on cancer screening

Introduction

In 2018, a biennial fecal immunochemical test (FIT) screening program for colorectal cancer (CRC) was introduced in northern Portugal, targeting 1.1 million residents aged 50-74 years.

Aims & Methods

This study aimed to evaluate trends in CRC incidence, early diagnosis, and survival before and after the program's implementation.
Population-based retrospective cohort study in northern Portugal. Data on CRC cases diagnosed between 2014-2020 were retrieved from the Portuguese National Cancer Registry (RON). Early diagnosis was defined as stage I/II tumors. Net survival estimates for 2014–2016 vs. 2018-2020 were compared. Data from RON were linked to the FIT-based screening program of the Northern Portugal Regional Health Administration for the years 2018–2020 to assess screening outcomes.

Results

Between 2018 and 2020, the first 3 years of the program, 482,938 invitations for FIT screening were sent, resulting in an adherence rate of 34.4% (165,895). The negative predictive value of FIT was 99.95% (95% CI: 99.94–99.96). Overall, coverage by FIT and/or colonoscopy was 44.9%. The proportion of early cancers was significantly higher among individuals submitted to FIT screening (58.3%) or colonoscopy (62.8%) compared to unscreened individuals (49.2%) (p<0.001). Net survival rates at 1-year and 3-years were significantly higher among individuals who accepted FIT screening or underwent colonoscopy compared to those who remained unscreened (p<0.001).

Conclusion

Biennial FIT led to an increase in early diagnoses and improved survival compared to no screening shortly after its introduction. A health system's comprehensive capacity boosts population coverage and improves CRC outcomes.

Introduction

Colorectal cancer (CRC) and other bowel diseases is a significant health concern globally. In several countries, the fecal immunochemical test (FIT) is a cornerstone in CRC screening for early detection of cancer in asymptomatic individuals. Moreover, the utility of FIT extends beyond this, as it is increasingly recommended for evaluating symptomatic patients as part of the clinical pathway to render possible or rule out serious bowel pathology. Therefore, we aimed to quantify the findings of serious bowel conditions following a non-screening FIT test in the Danish population.

Aims & Methods

This study investigated use of FIT beyond the national CRC screening program in Denmark. We aimed (1) to assess utilization patterns of FIT in contexts other than screening and (2) to examine ensuing diagnoses. Our goal was to quantify the findings of CRC and other bowel diseases in symptomatic patients, thereby assessing its broader potential.
This cohort study was conducted within the Danish universal public healthcare system, delivered by five administrative regions. National CRC screening using FIT was initiated in 2014, but utilization of FIT for symptomatic patients varies between regions. The cut-off for a positive test is ≥10 µg haemoglobin/g faeces for symptomatic populations.
The study used data from the Danish Civil Registration System, the Danish National Patient Registry covering all Danish hospitals, and the Clinical Laboratory Information Register. The cohort included all patients who underwent FIT between 2014 and 2021 outside the Danish CRC screening program.
We employed descriptive statistics to examine FIT administration and demographic distributions across the Danish regions, as well as fecal haemoglobin levels among tested individuals. In addition, we estimated the cumulative incidence of CRC and inflammatory bowel disease (IBD) diagnoses following FIT, considering death as a competing risk and evaluated the proportion of diagnoses for CRC and IBD during the year following FIT.

Results

We identified 19,787 individuals who underwent FIT outside the national CRC screening program in 2014 to 2021. Of these, 4,283 (22%) individuals had a positive FIT result. Among tested individuals, 10,807 (55%) were female. Median age at testing was 64 years. Use of FIT varied across the regions, with 36% of the study cohort being from the Central Denmark Region, and 1.6% being from the Region of Southern Denmark.
Positive FIT cases had a shorter median time to CRC diagnosis (28 days) and any diagnosis (36 days) compared to negative FIT cases (711 and 58 days, respectively). Within one year of the FIT, 370 (1.9%) individuals were diagnosed with CRC, with higher occurrence for FIT positive individuals (7.9%) than for FIT negative individuals (0.2%) (risk difference: 7.7 percentage points [95% CI: -3.2, 11.1]).
Among individuals with a positive FIT result, 83 (1.9%) were diagnosed with IBD within one year, compared to 51 (0.3%) individuals with a negative FIT (risk difference: 1.6 percentage points [95% CI: -5.8, 7.3]).

Conclusion

We found that FIT used outside the national CRC screening program had over 20% positivity. A positive test indicated higher risk of CRC and IBD. Differences in diagnoses are expected due to varied follow-up procedures after positive and negative FIT results. A negative test, while not definitive, suggests a potential to rule out disease and could reduce unnecessary investigations when assessing symptomatic patients.

Introduction

The fecal immunochemical test (FIT) is the preferred non-endoscopic test in programmatic screening worldwide. Compared to other methods, FIT may be better accepted with higher participation rates, which may counteract its lower one-time sensitivities. We performed a systematic review and meta-analysis to ascertain participation patterns, participation rates, and FIT performance in organized multi-round FIT-based screening programs worldwide.

Aims & Methods

We performed a systematic search using Pubmed, Embase, and Cochrane databases. Participation patterns were categorized as “consistent screeners” (participation in 100% of rounds), “intermittent screeners” (including drop-outs, delayed entrants, and intermittent re-screeners), and “consistent non-screeners” (never screened). Data regarding positivity rates and detection rates for adenomas, advanced adenomas (AA), and colorectal cancer (CRC) across subsequent rounds were extracted and summary estimates were obtained. Yields were calculated for 2 populations: 1) Overall Population; 2) Consistent Screeners. A sensitivity analysis was performed including only programs with biennial screening with FIT cut-off of 20μg Hb/g feces.

Results

The literature search yielded 4,414 studies of which 25 were included. Across all studies, the fraction of the population behaving as “consistent screeners”, “consistent non-screeners”, and “intermittent screeners” was 47.1%, 30.3%, and 22.7%, respectively. For the overall population, FIT-positivity from the 1^st through 4^th rounds was 6.7%, 5.5%, 5.4%, and 5.3%; and detection rates were 5.8%, 3.3%, 2.9%, and 2.5% for CRC; 32.8%, 28.3%, 22.7% and 23% for AA; 48.6%, 46.2%, 48.7% and 44.6% for adenoma. For Consistent Screeners, FIT-positivity across studies from the 1^st through 4^th rounds was 6.4%, 4.8%, 4.1%, and 3.6%, respectively; and detection rates were 6.9%, 4.6%, 3.6%, and 3.1% for CRC; 38.7%, 30.6%, 28.2% and 24.9% for AA; 53.4%, 46.7%, 42.6% and 42.4% for adenoma. Similar trends were observed for biennial screening with FIT cut-off of 20μg Hb/g feces.

Conclusion

Organized multi-round FIT-based CRC screening programs achieve consistent participation in a minority of participants, and a sizeable proportion of the population do not initiate screening at all after multiple offers. Among those participating, FIT-positivity, and yields for CRC, AA, and adenoma are highest in the 1^st round, but may stabilize at a clinically relevant steady state at rounds 3+.

References

1. Doria-Rose VP, Lansdorp-Vogelaar I, McCarthy S, Puricelli-Perin DM, Butera V, Segnan N, et al. Measures of longitudinal adherence to fecal-based colorectal cancer screening: Literature review and recommended approaches. Int J Cancer. 2021 Jul 15;149(2):316–26.
2. Duncan A, Turnbull D, Wilson C, Osborne JM, Cole SR, Flight I, et al. Behavioural and demographic predictors of adherence to three consecutive faecal occult blood test screening opportunities: A population study. BMC Public Health. 2014 Mar 7;14(1).

Introduction

Colorectal cancer (CRC) is one of the most commonly diagnosed types of cancer worldwide, ranking as the third most common neoplasia and the second leading cause of cancer-related deaths according to Global Cancer Statistics 2020 [1]. In Romania, CRC has the highest incidence rate, as reported by the Globocan platform in 2020, although the mortality rate follows global trends. The growing incidence of colorectal cancer poses a significant challenge to the global healthcare system [2].

Aims & Methods

Our aims are to assess and demonstrate the importance and value of a CRC screening program in early diagnosis among individuals aged 50 to 75 years in the southwestern of Oltenia, Romania. We prospectively enrolled apparently healthy individuals between 50 and 75 years old in a CRC prevention program at the University of Medicine and Pharmacy of Craiova, in the southwestern Oltenia region. The ongoing program started in November 2020. Exclusion criteria included individuals already enrolled in a screening program for CRC, with a personal history of colonic polyps, colorectal cancer, or inflammatory bowel diseases and individuals with a family history of inherited syndromes linked with CRC. Patients were identified based on the lists provided by participating general practitioners. All provided informed consent and completed a questionnaire regarding symptoms and family history of CRC. Based on their responses, patients were either offered a fecal immunochemical test (FIT) followed by colonoscopy in case of a positive result or were directly referred for colonoscopy. Those with negative results were instructed to repeat the test in two years.

Results

Until 24 April 2023 we enrolled 44,714 individuals (18,415 male, 41.18%). Of these, 38,610 (86.34%) received FITs, of whom 2,426 (6.28%) had a positive finding and 49 were directly referred for colonoscopy based on their questionnaire answers. We performed 1,262 colonoscopies, also having 1,004 refusals (41.38% of positive FITs) and 209 (8.61%) in waiting. Percentage of positive FIT tests correlated with older age (p<0.05). The chance of a positive colonoscopy finding correlated with the FIT value (p<0.05) and older age (p<0.05), while not being linked to either gender or provenance. We did not find lesions in 400 subjects (31.7% negative colonoscopies). In total, we found 2,092 significant lesions in 862 patients: 100 tumors and 1,992 polyps.

Conclusion

We provided here the first results of a large-scale CRC screening program in the Southwestern region of Romania, proving the importance of a coherent early detection strategy in the successful management of digestive malignancies. The high rate of colonoscopy refusals shows the need for an awareness campaign involving all medical and allied health personnel.

References

1.Sung, Hyuna et al. “Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.” CA: a cancer journal for clinicians vol. 71,3 (2021): 209-249. doi:10.3322/caac.21660 .
2. Jiang, Yufei et al. “Global pattern and trends of colorectal cancer survival: a systematic review of population-based registration data.” Cancer biology & medicine, vol. 19,2 175–186. 6 Sep. 2021, doi:10.20892/j.issn.2095-3941.2020.0634.

Introduction

The quantitative fecal immunochemical test (FIT) is widely used for colorectal cancer (CRC) screening. While the association between FIT concentration and the risk of advanced colorectal neoplasia (ACN) detection is well established, the predictive performance of current-round FIT concentration alone has limitations. Identifying additional predictive factors could enhance screening. For individuals with a prior colonoscopy, colonoscopy findings and quality metrics may serve as such factors.1 For those who did not undergo colonoscopy due to a negative FIT in the previous round, alternative predictors should be explored. We hypothesized that prior-round FIT concentration could serve as a potential predictor.

Aims & Methods

We aimed to investigate whether prior-round negative FIT concentration could predict CRC and ACN detection by conducting a cross-sectional analysis of data from the FIT arm of the SCREESCO, a nationwide randomized controlled trial on CRC screening in Sweden.1,2 A sample of the Swedish population aged 60 years was randomly assigned to one of three arms: the once-colonoscopy arm, FIT arm, or control arm. Individuals in the FIT arm were invited to undergo two rounds of quantitative FIT screening in the first and third years. A highly sensitive method was used to assess FIT positivity, with a cut-off concentration of ≥10 μg Hb/g feces. We estimated the detection rates of CRC and ACN in second-round colonoscopy based on first-round FIT concentration. Binary regression models were used to assess whether first-round FIT concentration was associated with CRC and ACN detection in the second round. The models included participant characteristics such as sex, body mass index, and smoking status, and second-round FIT concentration, in addition to first-round FIT concentration.

Results

A total of 1,991 individuals were included, with a median FIT concentration of 2.2 μg Hb/g feces (interquartile range: 0.4–4.6) in the first round and 21.8 (13.4–50.8) in the second round. CRC and ACN were detected during second-round colonoscopy in 23 (1.2%) and 267 (13.4%) individuals, respectively. Individuals with first-round FIT concentration of 0–1.9, 2.0–5.9, and 6.0–9.9 μg Hb/g feces had second-round CRC detection rates of 0.8%, 0.9%, and 2.6%, respectively, and ACN detection rates of 9.7%, 12.5%, and 15.9%, respectively. A higher first-round FIT concentration was associated with an increased risk of CRC (risk ratio per unit increase 1.27; 95% confidence interval 1.10–1.47) and ACN (1.08; 1.04–1.12) detection in the second round, after adjusting for the second-round FIT concentration and participant characteristics. For a fixed second-round FIT concentration, the absolute risk of second-round ACN detection increased with higher first-round FIT concentration. For instance, in a nonsmoking or ex-smoking male with a second-round FIT concentration of 20 µg Hb/g feces, the risk increased from 10.0% at < 0.2 µg Hb/g feces in the first round to 14.9% at 5 µg Hb/g feces and 19.6% at 9.9 µg Hb/g feces.

Conclusion

First-round negative FIT concentration is predictive of CRC and ACN detection in the second screening round. Even an increase in low levels of the FIT concentration is associated with future detection of these neoplasms. Incorporating first-round FIT concentration alongside second-round FIT concentration may enhance risk stratification in CRC screening, leading to more efficient use of colonoscopy resources.

References

1. Sekiguchi M, Westerberg M, Löwbeer C, Forsberg A. Gastrointest Endosc. 2025 Feb 4. doi: 10.1016/j.gie.2025.01.037. Epub ahead of print.
2. Forsberg A, Westerberg M, et al. Lancet Gastroenterol Hepatol. 20227: 513-21. doi: 10.1016/S2468-1253(21)00473-8.