scholarly journals Polyprev: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test with Endoscopic Surveillance after Advanced Adenoma Resection in Colorectal Cancer Screening Programs: A Study Protocol

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1520
Author(s):  
Cristina Regueiro ◽  
Raquel Almazán ◽  
Isabel Portillo ◽  
María Besó ◽  
Carlos Tourne-Garcia ◽  
...  

Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesion is detected, clinical practice guidelines recommend endoscopic surveillance with different intervals between explorations. Endoscopic surveillance is producing a considerable increase in the number of colonoscopies, with a limited effect on the CRC incidence. Instead, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non-inferior alternative to endoscopic surveillance to reduce 10-year CRC incidence. Based on this hypothesis, we have designed a multicenter and randomized clinical trial within the Spanish population CRC screening programs to compare FIT surveillance with endoscopic surveillance. We will include individuals aged from 50 to 65 years with complete colonoscopy and advanced lesions resected within the CRC screening programs. Patients will be randomly allocated to perform an annual FIT and colonoscopy if fecal hemoglobin concentration is ≥10 µg/g, or to perform endoscopic surveillance. On the basis of the non-superior CRC incidence, we will recruit 1894 patients in each arm. The main endpoint is 10-year CRC incidence and the secondary endpoints are diagnostic yield, participation, adverse effects, mortality and cost-effectiveness. Our results may modify the clinical practice after advanced colonic resection in CRC screening programs.

2021 ◽  
Vol 104 (7) ◽  
pp. 1067-1072

Background: Presently, the level of participation in screening programs for colorectal cancer (CRC) with Fecal Immunochemical Test (FIT) is considerably low. Objective: To investigate factors associated with participation in CRC screening using a FIT in the Thai population age 45 to 74 years in the Namphong District of Khon Kaen Province. Materials and Methods: In the present study, the unmatched case-control study design was applied. Three hundred ten participants were equally divided into two groups with 155 participants in the study group and the other 155 in the control group. The data were collected by conducting interviews. Moreover, to explain the association between the factors, multiple logistic regressions were used with adjusted odds ratio (ORadj), a confidence level at 95%, and with p<0.05. Results: It was found that ages were equal to or higher than 60 years (ORadj 2.08; 95%CI 1.19 to 3.63), the lower education level (ORadj 3.70; 95% CI 1.86 to 7.33), a family history of cancer (ORadj 5.25; 95% CI 2.14 to 12.86), receiving advice from public health officials regarding CRC screening (ORadj 3.09; 95% CI 1.81 to 5.27), and high level of knowledge about CRC (ORadj 4.01; 95% CI 2.09 to 7.69) had all been related to participation in the CRC screening program with a statistical significance (p<0.05). Conclusion: The results revealed that receiving advice from public health officials regarding CRC screening and that proper knowledge had been related to participation in screening programs for CRC with the FIT. Thus, to raise awareness and create a greater understanding, public health officers should disseminate knowledge about CRC. Information about the colorectal screening with the FIT should especially be spread to those people who are younger than 60 years of age, have educational levels higher than the primary level, and to those, who have no family history of CRC. Keywords: Colorectal Cancer Screening; Fecal Immunochemical Test (FIT); Thai population


PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243158
Author(s):  
Marta Malagón ◽  
Sara Ramió-Pujol ◽  
Marta Serrano ◽  
Joan Amoedo ◽  
Lia Oliver ◽  
...  

Guidelines recommend routine screening for colorectal cancer (CRC) in asymptomatic adults starting at age 50. The most extensively used noninvasive test for CRC screening is the fecal immunochemical test (FIT), which has an overall sensitivity for CRC of approximately 61.0%-91.0%, which drops to 27.0%-67.0% for advanced adenomas. These figures contain a high false-positive rate and a low positive predictive value. This work aimed to develop a new, noninvasive CRC screening tool based on fecal bacterial markers capable of decreasing FIT false-positive rates in a FIT-positive population. We defined a fecal bacterial signature (RAID-CRC Screen) in a proof-of-concept with 172 FIT-positive individuals and validated the obtained results on an external cohort of 327 FIT-positive subjects. All study participants had joined the national CRC screening program. In the clinical validation of RAID-CRC Screen, a sensitivity of 83.9% and a specificity of 16.3% were obtained for the detection of advanced neoplasm lesions (advanced adenomas and/or CRC). FIT 20 μg/g produced 184 false-positive results. Using RAID-CRC Screen, this value was reduced to 154, thus reducing the false-positive rate by 16.3%. The RAID-CRC Screen test could be implemented in CRC screening programs to allow a significant reduction in the number of colonoscopies performed unnecessarily for FIT-positive participants of CRC screening programs.


2021 ◽  
pp. 096914132199748
Author(s):  
Andrew Wang ◽  
Briton Lee ◽  
Shreya Patel ◽  
Evans Whitaker ◽  
Rachel B Issaka ◽  
...  

Objective Digital health care offers an opportunity to scale and personalize cancer screening programs, such as mailed outreach for colorectal cancer (CRC) screening. However, studies that describe the patient selection strategy and process for CRC screening are limited. Our objective was to evaluate implementation strategies for selecting patients for CRC screening programs in large health care systems. Methods We conducted a systematic review of 30 studies along with key informant surveys and interviews to describe programmatic implementation strategies for selecting patients for CRC screening. PubMed and Embase were searched since inception through December 2018, and hand searches were performed of the retrieved reference lists but none were incorporated ( n = 0). No language exclusions were applied. Results Common criteria for outreach exclusion included: being up-to-date with routine CRC screening ( n = 22), comorbidities ( n = 20), and personal history ( n = 22) or family history of cancer ( n = 9). Key informant surveys and interviews were performed ( n = 28) to understand data sources and practices for patient outreach selection, and found that 13 studies leveraged electronic medical care records, 10 studies leveraged a population registry (national, municipal, community, health), 4 studies required patient opt-in, and 1 study required primary care provider referral. Broad ranges in fecal immunochemical test completion were observed in community clinic ( n = 8, 31.0–59.6%), integrated health system ( n = 5, 21.2–82.7%), and national regional CRC screening programs ( n = 17, 23.0–64.7%). Six studies used technical codes, and four studies required patient self-reporting from a questionnaire to participate. Conclusion This systematic review provides health systems with the diverse outreach practices and technical tools to support efforts to automate patient selection for CRC screening outreach.


2020 ◽  
Vol 158 (6) ◽  
pp. S-1180-S-1181
Author(s):  
Temitayo Gboluaje ◽  
Martha Gwengi ◽  
Titi Olanipekun ◽  
Taiwo A. Ajose ◽  
Krystal Mills ◽  
...  

2021 ◽  
Vol 8 ◽  
Author(s):  
Ru-chen Zhou ◽  
Pei-zhu Wang ◽  
Yue-yue Li ◽  
Yan Zhang ◽  
Ming-jun Ma ◽  
...  

Objective: The diagnostic efficiency of the quantitative fecal immunochemical test (qFIT) has large variations in colorectal cancer (CRC) screening. We aimed to explore whether the practical sample collection operant training could improve the diagnostic accuracy of the qFIT in CRC screening.Methods: Moderate-/high-risk individuals aged 50–75 years old were invited to participate in a prospective observational study between July 2020 and March 2021. Participants took a qFIT sample without fecal sample collection operant training in advance and then completed another qFIT sample after the operant training. The primary outcome was the sensitivity and specificity of the qFITs for CRC and advanced colorectal neoplasia (ACRN). The secondary outcome was the difference in the area under the curves (AUCs) and the concentrations of the fecal hemoglobin (Hb) between the qFIT without and after the operant training.Results: Out of 913 patients, 81 (8.9%) patients had ACRN, including 25 (2.7%) patients with CRC. For CRC, the sensitivities of the qFIT without and after the operant training at 10 μg/g were 80.4 and 100.0%, respectively, and the specificities were 90.1 and 88.4%, respectively. For ACRN, the sensitivities were 49.4 and 69.1% and the specificities were 91.7 and 91.3%, respectively. The AUC of the qFIT after the operant training was significantly higher than that without the operant training for CRC (p = 0.027) and ACRN (p = 0.001). After the operant training, the concentration of the fecal Hb was significantly higher than that without the operant training (p = 0.009) for ACRN, but there was no significant difference for CRC (p = 0.367).Conclusion: Practical sample collection operant training improves the diagnostic accuracy of the qFIT, which increases the detection of the low concentrations of fecal Hb. Improving the quality of the sample collection could contribute to the diagnostic efficiency of the qFIT in CRC screening.


2020 ◽  
pp. 525-531
Author(s):  
Elizabeth O. Labaeka ◽  
Achiaka E. Irabor ◽  
David O. Irabor

PURPOSE Colorectal cancer (CRC) is a disease of public health importance because of the increasing incidence of the disease and presentation in advanced stage of the disease in Western Africa. CRC is amenable to screening because of the long course of premalignant lesions before final development of the disease. Despite this, the practice of CRC screening is inadequate at the sites in this study. The fecal immunochemical test (FIT) is one of the recommended noninvasive methods for CRC screening. It has a sensitivity of 96%, specificity of 90%, and an overall accuracy of 95%. We aimed to determine the practicability of FIT for CRC screening in patients aged 40 to 75 years who attended primary care clinics in the University College Hospital, Ibadan, Nigeria. PATIENTS AND METHODS A total of 422 patients selected by systematic random sampling were recruited and offered free FIT screening. Participants with a positive finding had additional GI examination, including a digital rectal examination, proctoscopy, and colonoscopy, if no lesion was biopsied during proctoscopy. RESULTS The mean (± standard deviation) age of the respondents was 62 ± 9.61 years. The prevalence of a positive FIT in the study was 10.1%. The FIT was not completed by 3.8% of patients, and the rate of completion of additional evaluation after a positive FIT reduced as the investigations became invasive, with 36.8% and 71.1% noncompletion rates for proctoscopy and colonoscopy, respectively. CONCLUSION A FIT-based screening for age and risk-appropriate patients is practical in this environment, where the capacity and acceptability of colonoscopy are limited.


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