Acquisition, analysis, or interpretation of data: All authors. The American Cancer Society estimates more than 153,000 Americans will be diagnosed with colorectal cancer this year making it one of the most common cancers in both men and women. Conclusions and Relevance Among patients with a positive fecal immunochemical test result, compared with follow-up colonoscopy at 8 to 30 days, follow-up after 10 months was associated with a higher risk of colorectal cancer and more advanced-stage disease at the time of diagnosis. DC, Curry Diagnostic studies evaluating the accuracy of FIT for CRC or AN in patients with a personal or familial history of CRC using colonoscopy as the reference standard. M, Gimeno-Garcia J, Kallenberg JY, Chan U. DA, McFarland From these findings, they concluded that a periodic FIT was an accurate test in people with average CRC risk. Can have false-positive test results. et al. Otero-Estevez The area under the ROC (AUC) for diagnosis of CRC and AN was 0.93 (95% CI, 0.90-0.95) and 0.86 (95% CI, 0.83-0.89), respectively (eFigure 4 in the Supplement). Less than 1 percent of these (601 cases) were advanced cancers. Of the 432 participants who had a positive fecal immunochemical test, 285 underwent a colonoscopy (235 participants showed no polyps or cancer, 47 had polyps identified, and three had colorectal cancer identified). LA, Nearly all of the people who had a follow-up colonoscopy did so within a year of the positive FIT result. If cancer is detected, treatment is usually the next step. We assessed the quality of the evidence in our main analysis but also separately for patients with family history or personal history of CRC. It has recently been suggested that fecal immunochemical testing (FIT) could be used for population-based screening owing to its high accuracy and adherence.7-9 Previous systematic reviews and meta-analyses have assessed the performance of FIT in average-risk populations.10,11 However, the potential role of FIT for screening of individuals at increased risk for CRC has not yet been fully elucidated. Bossuyt CLN Stat The new faecal immunochemical test (FIT) is due to be introduced into the bowel cancer screening programme (BCSP) in England later this year to replace the current test. et al. The trials reported a low positive predictive value (PPV) for the FOBT test, suggesting that most positive tests were false positives. Brozek E, Castells Stool samples collected at home are sent in for analysis. The FIT identified patients with CRC with overall high sensitivity but missed nearly 50% of small (T1) and 32% of UICC stage I CRCs. NCCN Guidelines For Colorectal Cancer Screening (Version 2.2016). DG. FIT has high overall diagnostic accuracy for CRC in increased-risk individuals. This review was based on a prespecified protocol registered with PROSPERO 2016 (CRD42016037924) and is reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement.12. Despite the use of an exhaustive and meticulous search strategy, we could only find 12 eligible studies. P, Hazazi The FIT test, or fecal immunochemical blood test, is a newer and more accurate way to test for blood in stool, which can be a symptom of colon cancer. 51% will have a precancerous polyp. moderator 3rd September 2020. KG. Low adherence to colonoscopy in the screening of first-degree relatives of patients with colorectal cancer. In recent years fecal immunochemical tests (FITs) have been offered as a primary screening test for colorectal cancer (CRC) in a growing number of countries. Methods The FIT-based CRC screening programme in the Veneto region (Italy) invited persons aged 50 to 69 . JY, Chan 2017;177(8):11101118. et al. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. et al. Pooled test characteristics estimates for diagnosing CRC were sensitivity, 86% (95% CI, 31%-99%); specificity, 91% (95% CI, 89%-93%); LR+, 10.00 (95% CI, 5.80-17.5); and LR, 0.16 (95% CI, 0.02-1.48). Nevertheless, all included studies evaluated 1-time application of the test, and results could not be transferred to repeat screening programs. L, It tests for hidden blood in the stool, which can be an early sign of cancer. The researchers compared the numbers of new colorectal cancer cases diagnosed, deaths from colorectal cancer, and deaths from any cause in the two groups over time for up to 10 years after an initial positive FIT result. The main advantage of this test, which costs . We excluded studies with symptomatic patients or patients with inflammatory bowel disease, hereditary nonpolyposis colorectal cancer, familial adenomatous polyposis, or studies for which 22 diagnostic tables could not be inferred. Berger High specificity and sensitivity of FIT allow prompt referral of patients with positive results for further diagnostic investigation with colonoscopy, and exclusion of CRC with high certainty in individuals with negative results respectively. Bowel cancer (colorectal cancer, CRC) is the second most common cause of cancer death in the UK, accounting for 10% of all cancer deaths in 2017. Eleven studies were cross-sectional and 1 was a randomized clinical trial.34 Two studies were reported only in abstract form.26,36 Nine studies included only first-degree relatives of CRC patients.26-28,30,32-34,36,37 Three studies included individuals either with a family history of CRC or prior history of CRC or advanced adenomas.29,31,35 Of these, only 2 studies reported results for subgroups.31,35, Eight studies evaluated quantitative FIT (OC-sensor/OC-micro, Eiken Chemical),26,27,29,31,33-36 while 4 studies used qualitative FITs (Hemosure, W.H.P.M. The positive test result Bayesian multiplier (here, 6.8) raised our estimate of the probability of colon cancer from 0.7% to 5%, supporting getting the colonoscopy, which turned out to be negative (no cancer detected). Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. M, P, Leshno Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. FIT only detects human blood from the lower intestines. S, ed. Main Characteristics of Studies Included in the Systematic Review and Meta-analysis, Table 2. Quantitative and 1-sample FIT showed adequate test performance, but data on other FIT brands and multiple samples were insufficient. R, This test uses antibodies that specifically react with a blood protein in the stool. The study points to the importance of more closely monitoring people who do not follow recommendations after a positive FIT result, said Erica Breslau, Ph.D., M.P.H., of NCIs Healthcare Delivery Research Program, who also was not involved in the study. 12 Data from outside the United States . H, Bishehsari JA, Eisen van Rossum The main findings of our study. MA, Perdue EA, Alonso-Coello For the study, Manuel Zorzi, M.D., M.Sc., of the Veneto Tumour Registry in Padua, Italy, and his colleagues, examined the medical records of participants in a regional colorectal screening program who took a FIT test between January 1, 2004, and September 30, 2017. LG, van Rijn and P.P.) The first stool tests developed were based on the finding of occult, or hidden, blood. JD, Armitage Levi PF, Rutjes If you get a positive Cologuard result, it means the test detected signs of colon cancer or precancerous polyps. This is especially important for those who are averse to colonoscopy. Effectiveness: According to the USPSTF report, when the patient has colon cancer, the test is likely to indicate its presence 62% to 79% of the time. // The FIT identified that there was blood in the stool. This study doesnt help us understand why people arent following up, Dr. Corley said. What is the diagnostic accuracy of fecal immunochemical testing (FIT) for screening of colorectal cancer (CRC) or advanced neoplasia in asymptomatic high-risk populations? Appropriateness of colonoscopy in Europe (EPAGE II). Because the fecal occult blood test (FOBT) was not as accurate, the fecal immunochemical test (FIT) was developed. Conflict of Interest Disclosures: None reported. FA, Terhaar Sive Droste Assuming a pretest probability of 0.8% for CRC and 10.2% for AN (median prevalence in 7 and 12 studies included in the present meta-analysis, respectively), a positive result increases the probability of CRC to 8.0% and probability of AN to 42.0%. Hierarchical summary receiver operating curve (HSROC) plot of sensitivity versus specificity of FIT for diagnosis of a) colorectal cancer; b) advanced neoplasia, eFigure 5. Schnemann H, Brozek J, Guyatt G, Oxman A, ed; GRADE Working Group. Date: DEC.17.2020 We assessed quality using a meticulous, recently developed tool (QUADAS-2). In the colonoscopy group, the number of new colorectal cancers diagnosed went up sharply in the first 6 months or so after a positive FIT result and leveled off after that. Individuals at average risk are screened using the fecal immunochemical test (FIT), which has been available in British Columbia for the past 5 years PM, Zwinderman Collectively, two studies found that FIT performs poorly in identifying early-stage CRC but serves some benefit as a periodic screening tool. We converted units for FIT cutoff thresholds to micrograms of hemoglobin (Hb) per gram of feces.14 Two authors (A.K. Fecal immunochemical test (FIT). To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk. PS, Bostock It is thus imperative for future studies to include larger and better-defined patient populations. Quiz Ref IDThe type of FIT used and cutoff threshold were the most important contributors to the heterogeneity of results. MEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016. Importance Chubak et al reported that the return rate of any stool blood test after kit mailing within 6 months was 69% versus 64% (P < .005) for 1-sample versus 2-sample testing, respectively, 11 whereas Mosen et al reported that the kit return rate within 6 months was 43.4% versus 39.6% (P = .012), respectively. M, Ko Given the safety, simplicity, low cost, and minimal discomfort of FIT, it is a viable alternative screening strategy for patients at increased risk for CRC. FIT (Fecal Immunochemical Test) is a stool test used to look for possible signs of colorectal cancer. The potential role of the fecal immunochemical test (FIT) for screening patients at increased risk for colorectal cancer (CRC) has not yet been elucidated. Quantitative and 1-sample FIT showed adequate test performance, but data on other FIT brands and multiple samples were insufficient. Most of these were at high or unclear risk of bias due to suboptimal study design.26,28,30,32,34,36,37 Only 3 studies had a mixed population with personal or familial history of CRC,29,31,35 and 2 studies presented results separately based on the patient history.31,35 A post hoc analysis of studies in individuals with family history of CRC using quantitative FIT resulted in similar summary estimates with the main analysis. Quality assessment summary: review authors judgments about each risk of bias item for each included study, eFigure 3. It is also important to establish optimal thresholds, test cutoff values, and number and frequency of FIT samples.10 Our results also should prompt randomized trials to assess the implementation of FIT either alone or in combination with other screening procedures into screening strategies for increased-risk individuals. Finally, we explored the clinical utility of FIT for patients at increased risk of CRC by means of Fagan nomogram. Used not only as a screening test, colonoscopies are also used as a diagnostic procedure to follow up after positive results from a fecal occult blood test (FOBT) or fecal immunochemical test (FIT), fecal DNA test, sigmoidoscopy . AZ, Quintero However, the validity of our conclusions is undermined by low or very low quality of the body of evidence. National Comprehensive Cancer Network. eFigure 2. HermannBrenner,MD, MPH; SilviaCalderazzo,PhD; ThomasSeufferlein,MD; LeopoldLudwig,MD; NektariosDikopoulos,MD; JrgMangold,MD; WolfgangBck,MD; ThomasStolz,MD; ThomasEisenbach,MD; ThomasBlock,MD; AnnetteKopp-Schneider,PhD; DavidCzock,MD; KajaTikk,PhD, Fecal Immunochemical Tests in Patients at Increased Risk for CRC, Assessment of Quality of Body of Evidence, Get the latest from JAMA Internal Medicine, To register for email alerts, access free PDF, and more, Get unlimited access and a printable PDF ($40.00), 2023 American Medical Association. Stool DNA testing. JE, Halloran Based on GRADE summaries (eTable 2 in the Supplement) we deemed the quality of the evidence to be low or very low. Screening for colorectal cancer: updated evidence report and systematic review for the US Preventive Services Task Force. by Carmen Phillips, December 2, 2022, On subsequent colonoscopy, 40% of those with positive tests had either advanced adenomas or cancer. Some people may have had other illnesses that precluded them from having a colonoscopy or made them feel that they were more likely to die from causes other than colorectal cancer, he explained. FIT (Faecal Immunochemical Test) is a test that looks for blood in a sample of your poo. The Cologuard test has a 12% false-positive rate, which means 1 in 10 positive tests will incorrectly identify cancer or polyps. We included studies that reported the diagnostic accuracy of FIT for CRC or advanced neoplasia (CRC, or adenomas 10 mm or with 25% villous component and/or high-grade dysplasia) in asymptomatic adults with family history of CRC or personal history of CRC or advanced adenomas and used colonoscopy or follow-up as the reference standard. Tests and investigations for colorectal cancer screening. In the case of permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title; e.g., Colonoscopy after Positive FIT Test Cuts Risk of Colorectal Cancer Death was originally published by the National Cancer Institute., January 12, 2023, There are two types of stool tests for colon cancer. We also conducted a sensitivity analysis including data only from patients with family history of CRC. Quiz Ref IDColonoscopy is currently the only recommended screening modality for participants at increased risk of CRC owing to personal or family history.3 However, no study has documented the effectiveness of this policy on CRC incidence or mortality. Surveillance after polypectomy and after resection of colorectal cancer. New research underlines the importance of following up with a colonoscopy exam after a positive (abnormal) result on an at-home stool test to screen for colorectal cancer. When a guaiac FOBT is performed every one to two years in adults 50 to 80 years old, it can reduce deaths from colorectal cancer by 15 to 33 percent, according to the National Cancer Institute . and P.P.) They said, it just states either negative or positive for cancer. This study shows that even with a national health service that provides universal coverage, there are other barriers to obtaining care, Dr. Breslau said. To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk. Having a stool DNA test may lead to additional testing. Terms of Use| Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. That . Rutter We also searched trial registries and abstracts from relevant scientific meetings, as well as scanned websites of companies manufacturing FITs. FN indicates false-negative results; FP, false-positive results; TN, true-negative results; TP, true-positive results. Parekh . The Cologuard test has a 13% false-positive rate, which means 1 in 10 positive tests will incorrectly identify cancer or polyps. For example, peoples fears about the preparation for colonoscopy continue to be a major barrier. The accuracy for advanced neoplasia however is moderate, and so further study of annual FIT to assess increased performance is warranted. I asked what did it show, because they test for 11 different cancers or categories. and P.P.) JB, Linnet Brozek After deduplication, 2154 titles and abstracts were screened and 1952 records were rejected or deemed ineligible. We fitted hierarchical logistic regression models when 4 or more studies were available.21-24. The average sensitivity of FIT for AN was 48% (95% CI, 39%-57%); and the average specificity was 93% (95% CI, 91%-94%), yielding an LR+ of 6.55 (95% CI, 5.0-8.5) and an LR of 0.57 (95% CI, 0.48-0.67) (GRADE: very low). FIT costs about $20 or less and is covered by Medicare and most health insurance plans. The average sensitivity of FIT for CRC was 93% (95% CI, 53%-99%), and the average specificity was 91% (95% CI, 89%-92%), yielding a positive likelihood ratio (LR+) of 10.30 (CI 7.7-13.9) and a negative likelihood ratio (LR) of 0.08 (95% CI, 0.01-0.75) (GRADE: very low). A positive FIT is not a colorectal cancer diagnosis, but we do know that it can cause a great deal of anxiety. FJ, [This] raises the importance of being able to get the individual steps correct and completed as best you can because every step where you lose some people in follow-up can have a big impact., Study Adds to Debate about Screening for Melanoma, Ivosidenib with Chemotherapy New Option for Some People with AML, If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. Any disagreement was resolved through discussion or by consulting a third author (A.T.). Applying Grading of Recommendations Assessment, Development and Evaluation (GRADE) to diagnostic tests was challenging but doable. This specific protein attaches to hemoglobin, the oxygen-carrying part of red blood cells. AZ, Thus, our results suggest that in increased-risk individuals FIT has high diagnostic accuracy for CRC. C, SC, The FIT identified patients with CRC with overall high sensitivity but missed nearly 50% of small (T1) and 32% of UICC stage I CRCs.
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