Precise Colorectal Cancer Screening Based on Customized Intervals Using Fecal Hemoglobin Concentration

Researchers: Amy Ming-Fang Yen, Yang-Ching Chen, Yu-Lin Ding, Wen-Zhu Qiu, Han-Mo Qiu, Tony Hsiu-Hsi Chen, Sam Li-Sheng Chen

Academic Background

Colorectal cancer (CRC) is the third most prevalent malignancy worldwide. In recent years, significant progress has been made in CRC screening for prevention and early detection, largely due to the implementation of population-based screening programs and advances in treatment methods. Among these tools, the fecal immunochemical test (FIT) plays a crucial role in reducing CRC mortality. Despite the proven effectiveness of CRC screening, which provides primary prevention through the removal of pre-cancerous adenomas via colonoscopy and lowers CRC-related mortality through early detection, further investigation is needed to leverage fecal biomarkers to comprehensively categorize populations and optimize screening strategies.

Source of the Paper

This study, written by Amy Ming-Fang Yen and other scholars from institutions such as Taipei Medical University and National Taiwan University, was published in JAMA Oncology on May 9, 2024.

Objective of the Study

The objective of this research is to demonstrate the applicability of screening intervals guided by fecal hemoglobin (f-Hb) for personalized CRC screening. This approach aims to reduce the required number of FIT and colonoscopies while maintaining the effectiveness equivalent to the common biennial screening.

Research Design and Data Sources

Using a retrospective cohort study design, the research utilized data from over 3 million participants aged 50 to 74 in Taiwan, collected from 2004 to 2014 as part of the national biennial FIT screening program. Participants were tracked until 2019 to identify CRC incidence and mortality causes. Additionally, a comparative study was designed to contrast the personalized f-Hb-guided group with the standard biennial screening group regarding FIT and colonoscopy usage.

Research Process

Sample Collection Process

Samples were collected using two FIT testing tools, OC-Sensor and HM-Jack. Participants self-sampled at home and returned the samples to the laboratory within the required timeframe without specific dietary or medication restrictions.

Data Collection

Quantitative data, including age, gender, screening date, and f-Hb results, were extracted from the central screening database. Individuals with baseline or repeated f-Hb readings exceeding the pre-set cut-off value (20 μg Hb/g) were recommended for colonoscopy to confirm colorectal tumors. This cohort was tracked until 2019 to ascertain CRC incidence and mortality.

Data Analysis

Poisson regression models were adopted to determine the association between f-Hb concentration levels and CRC mortality. Similar analytical methods were applied to interval cancers and advanced CRC studies. Using this model, researchers calculated CRC mortality rates corresponding to different f-Hb categories and recommended screening intervals based on these f-Hb levels.

By comparing average risk groups, the recommended screening intervals for each f-Hb category could be adjusted to reduce false positive and false negative results. For instance, participants with higher f-Hb levels should undergo more frequent confirmatory tests, whereas those with lower f-Hb levels could extend their screening intervals.

Results

By analyzing data from 3,487,559 participants, the study found that CRC incidence and mortality rates were positively correlated with f-Hb levels; participants with higher f-Hb levels had significantly increased CRC incidence and mortality. Based on these findings, the researchers recommended personalized screening intervals for different f-Hb levels and found that this approach could reduce the required numbers of FIT and colonoscopy tests by 49% and 28%, respectively.

Conclusion

Utilizing the gradient relationship between f-Hb concentration and colorectal tumors, the study developed personalized FIT screening intervals guided by f-Hb concentrations. These precise screening intervals not only reduce the use of FIT tests and colonoscopies but also maintain the effectiveness of screening. This indicates that personalized, f-Hb-guided screening has potential advantages in optimizing medical resource allocation.

Study Highlights

1. Precise Personalized Screening: Customizing screening intervals using f-Hb concentrations can be more efficient and resource-saving.
2. Significantly Reduced Testing Frequency: Compared to universal biennial screening, nearly half of the FIT test demand and over a quarter of the colonoscopy demand are reduced.
3. Extensive Data Support: The study is based on large-scale national screening data from Taiwan, making the conclusions broadly representative and practical.

Significance of the Study

This study not only confirms the gradient relationship between f-Hb levels and colorectal tumors and mortality rates but also proposes strategies for achieving precise screening intervals in population-based FIT screening. This helps optimize the use of FIT and colonoscopy, improving the efficiency of resource allocation in screening and reducing the burden on patients and healthcare systems.

Limitations and Future Prospects

Despite the large sample size and long-term tracking data, the study has certain limitations, such as the exclusion of other factors that might affect CRC risk. Future research should consider additional variables such as family history, body mass index, and smoking status to further enhance screening accuracy. This study opens new avenues for the application of fecal immunochemical testing in CRC screening and provides robust data support and theoretical basis for personalized screening.