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JAMA Nov 2023Noninvasive tests for colorectal cancer screening must include sensitive detection of colorectal cancer and precancerous lesions. These tests must be validated for the... (Comparative Study)
Comparative Study
IMPORTANCE
Noninvasive tests for colorectal cancer screening must include sensitive detection of colorectal cancer and precancerous lesions. These tests must be validated for the intended-use population, which includes average-risk individuals 45 years or older.
OBJECTIVE
To evaluate the sensitivity and specificity of a noninvasive, multitarget stool RNA (mt-sRNA) test (ColoSense) test compared with results from a colonoscopy.
DESIGN, SETTING, AND PARTICIPANTS
This phase 3 clinical trial (CRC-PREVENT) was a blinded, prospective, cross-sectional study to support a premarket approval application for a class III medical device. A total of 8920 participants were identified online using social media platforms and enrolled from June 2021 to June 2022 using a decentralized nurse call center. All participants completed the mt-sRNA test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center. The mt-sRNA test results (positive or negative) were compared with index lesions observed on colonoscopy. Over the course of 12 months, individuals 45 years and older were enrolled in the clinical trial using the decentralized recruitment strategy. Participants were enrolled from 49 US states and obtained colonoscopies at more than 3800 different endoscopy centers.
MAIN OUTCOMES AND MEASURES
The primary outcomes included the sensitivity of the mt-sRNA test for detecting colorectal cancer and advanced adenomas and the specificity for no lesions on colonoscopy.
RESULTS
The mean (range) age of participants was 55 (45-90) years, with 4% self-identified as Asian, 11% as Black, and 7% as Hispanic. Of the 8920 eligible participants, 36 (0.40%) had colorectal cancer and 606 (6.8%) had advanced adenomas. The mt-sRNA test sensitivity for detecting colorectal cancer was 94%, sensitivity for detecting advanced adenomas was 46%, and specificity for no lesions on colonoscopy was 88%. The mt-sRNA test showed significant improvement in sensitivity for colorectal cancer (94% vs 78%; McNemar P = .01) and advanced adenomas (46% vs 29%; McNemar P < .001) compared with results of the FIT.
CONCLUSIONS AND RELEVANCE
In individuals 45 years and older, the mt-sRNA test showed high sensitivity for colorectal neoplasia (colorectal cancer and advanced adenoma) with significant improvement in sensitivity relative to the FIT. Specificity for no lesions on colonoscopy was comparable to existing molecular diagnostic tests.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04739722.
Topics: Aged; Aged, 80 and over; Humans; Middle Aged; Adenoma; Colonoscopy; Colorectal Neoplasms; Cross-Sectional Studies; Early Detection of Cancer; Feces; Mass Screening; Occult Blood; Prospective Studies; RNA, Small Untranslated; RNA; Immunochemistry
PubMed: 37870871
DOI: 10.1001/jama.2023.22231 -
The New England Journal of Medicine Apr 2014The proportion of screening colonoscopic examinations performed by a physician that detect one or more adenomas (the adenoma detection rate) is a recommended quality...
BACKGROUND
The proportion of screening colonoscopic examinations performed by a physician that detect one or more adenomas (the adenoma detection rate) is a recommended quality measure. However, little is known about the association between this rate and patients' risks of a subsequent colorectal cancer (interval cancer) and death.
METHODS
Using data from an integrated health care delivery organization, we evaluated the associations between the adenoma detection rate and the risks of colorectal cancer diagnosed 6 months to 10 years after colonoscopy and of cancer-related death. With the use of Cox regression, our estimates of attributable risk were adjusted for the demographic characteristics of the patients, indications for colonoscopy, and coexisting conditions.
RESULTS
We evaluated 314,872 colonoscopies performed by 136 gastroenterologists; the adenoma detection rates ranged from 7.4 to 52.5%. During the follow-up period, we identified 712 interval colorectal adenocarcinomas, including 255 advanced-stage cancers, and 147 deaths from interval colorectal cancer. The unadjusted risks of interval cancer according to quintiles of adenoma detection rates, from lowest to highest, were 9.8, 8.6, 8.0, 7.0, and 4.8 cases per 10,000 person-years of follow-up, respectively. Among patients of physicians with adenoma detection rates in the highest quintile, as compared with patients of physicians with detection rates in the lowest quintile, the adjusted hazard ratio for any interval cancer was 0.52 (95% confidence interval [CI], 0.39 to 0.69), for advanced-stage interval cancer, 0.43 (95% CI, 0.29 to 0.64), and for fatal interval cancer, 0.38 (95% CI, 0.22 to 0.65). Each 1.0% increase in the adenoma detection rate was associated with a 3.0% decrease in the risk of cancer (hazard ratio, 0.97; 95% CI, 0.96 to 0.98).
CONCLUSIONS
The adenoma detection rate was inversely associated with the risks of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer. (Funded by the Kaiser Permanente Community Benefit program and the National Cancer Institute.).
Topics: Adenoma; Aged; Colonoscopy; Colorectal Neoplasms; Humans; Middle Aged; Risk; United States
PubMed: 24693890
DOI: 10.1056/NEJMoa1309086 -
The New England Journal of Medicine Feb 2012In the National Polyp Study (NPS), colorectal cancer was prevented by colonoscopic removal of adenomatous polyps. We evaluated the long-term effect of colonoscopic...
BACKGROUND
In the National Polyp Study (NPS), colorectal cancer was prevented by colonoscopic removal of adenomatous polyps. We evaluated the long-term effect of colonoscopic polypectomy in a study on mortality from colorectal cancer.
METHODS
We included in this analysis all patients prospectively referred for initial colonoscopy (between 1980 and 1990) at NPS clinical centers who had polyps (adenomas and nonadenomas). The National Death Index was used to identify deaths and to determine the cause of death; follow-up time was as long as 23 years. Mortality from colorectal cancer among patients with adenomas removed was compared with the expected incidence-based mortality from colorectal cancer in the general population, as estimated from the Surveillance Epidemiology and End Results (SEER) Program, and with the observed mortality from colorectal cancer among patients with nonadenomatous polyps (internal control group).
RESULTS
Among 2602 patients who had adenomas removed during participation in the study, after a median of 15.8 years, 1246 patients had died from any cause and 12 had died from colorectal cancer. Given an estimated 25.4 expected deaths from colorectal cancer in the general population, the standardized incidence-based mortality ratio was 0.47 (95% confidence interval [CI], 0.26 to 0.80) with colonoscopic polypectomy, suggesting a 53% reduction in mortality. Mortality from colorectal cancer was similar among patients with adenomas and those with nonadenomatous polyps during the first 10 years after polypectomy (relative risk, 1.2; 95% CI, 0.1 to 10.6).
CONCLUSIONS
These findings support the hypothesis that colonoscopic removal of adenomatous polyps prevents death from colorectal cancer. (Funded by the National Cancer Institute and others.).
Topics: Adenoma; Adenomatous Polyps; Aged; Colonic Polyps; Colonoscopy; Colorectal Neoplasms; Female; Follow-Up Studies; Humans; Male; Middle Aged
PubMed: 22356322
DOI: 10.1056/NEJMoa1100370 -
Gut Oct 2019The effect of colonoscopy on colorectal cancer mortality is limited by several factors, among them a certain miss rate, leading to limited adenoma detection rates... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The effect of colonoscopy on colorectal cancer mortality is limited by several factors, among them a certain miss rate, leading to limited adenoma detection rates (ADRs). We investigated the effect of an automatic polyp detection system based on deep learning on polyp detection rate and ADR.
DESIGN
In an open, non-blinded trial, consecutive patients were prospectively randomised to undergo diagnostic colonoscopy with or without assistance of a real-time automatic polyp detection system providing a simultaneous visual notice and sound alarm on polyp detection. The primary outcome was ADR.
RESULTS
Of 1058 patients included, 536 were randomised to standard colonoscopy, and 522 were randomised to colonoscopy with computer-aided diagnosis. The artificial intelligence (AI) system significantly increased ADR (29.1%vs20.3%, p<0.001) and the mean number of adenomas per patient (0.53vs0.31, p<0.001). This was due to a higher number of diminutive adenomas found (185vs102; p<0.001), while there was no statistical difference in larger adenomas (77vs58, p=0.075). In addition, the number of hyperplastic polyps was also significantly increased (114vs52, p<0.001).
CONCLUSIONS
In a low prevalent ADR population, an automatic polyp detection system during colonoscopy resulted in a significant increase in the number of diminutive adenomas detected, as well as an increase in the rate of hyperplastic polyps. The cost-benefit ratio of such effects has to be determined further.
TRIAL REGISTRATION NUMBER
ChiCTR-DDD-17012221; Results.
Topics: Adenoma; China; Colonic Polyps; Colonoscopy; Colorectal Neoplasms; Early Detection of Cancer; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Prospective Studies; Reproducibility of Results; Time Factors
PubMed: 30814121
DOI: 10.1136/gutjnl-2018-317500 -
Gastroenterology Sep 2022Colonoscopy for colorectal cancer screening is endoscopist dependent, and colonoscopy quality improvement programs aim to improve efficacy. This study evaluated the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND & AIMS
Colonoscopy for colorectal cancer screening is endoscopist dependent, and colonoscopy quality improvement programs aim to improve efficacy. This study evaluated the clinical benefit and safety of using a computer-aided detection (CADe) device in colonoscopy procedures.
METHODS
This randomized study prospectively evaluated the use of a CADe device at 5 academic and community centers by US board-certified gastroenterologists (n = 22). Participants aged ≥40 scheduled for screening or surveillance (≥3 years) colonoscopy were included; exclusion criteria included incomplete procedure, diagnostic indication, inflammatory bowel disease, and familial adenomatous polyposis. Patients were randomized by endoscopist to the standard or CADe colonoscopy arm using computer-generated, random-block method. The 2 primary endpoints were adenomas per colonoscopy (APC), the total number of adenomas resected divided by the total number of colonoscopies; and true histology rate (THR), the proportion of resections with clinically significant histology divided by the total number of polyp resections. The primary analysis used a modified intention-to-treat approach.
RESULTS
Between January and September 2021, 1440 participants were enrolled to be randomized. After exclusion of participants who did not meet the eligibility criteria, 677 in the standard arm and 682 in the CADe arm were included in a modified intention-to-treat analysis. APC increased significantly with use of the CADe device (standard vs CADe: 0.83 vs 1.05, P = .002; total number of adenomas, 562 vs 719). There was no decrease in THR with use of the CADe device (standard vs CADe: 71.7% vs 67.4%, P for noninferiority < .001; total number of non-neoplastic lesions, 284 vs 375). Adenoma detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (P = .065).
CONCLUSIONS
For experienced endoscopists performing screening and surveillance colonoscopies in the United States, the CADe device statistically improved overall adenoma detection (APC) without a concomitant increase in resection of non-neoplastic lesions (THR).
CLINICALTRIALS
gov registration: NCT04754347.
Topics: Adenoma; Colonic Polyps; Colonoscopy; Colorectal Neoplasms; Computers; Early Detection of Cancer; Humans
PubMed: 35643173
DOI: 10.1053/j.gastro.2022.05.028 -
La Tunisie MedicaleColonoscopy is considered as the most effective tool for preventing, screening, and diagnosing colorectal lesions. Effectiveness of colonoscopy was identified as a major... (Review)
Review
Colonoscopy is considered as the most effective tool for preventing, screening, and diagnosing colorectal lesions. Effectiveness of colonoscopy was identified as a major priority, and it strictly depends on quality measures. Therefore, international guidelines were formulated on quality indicators for colonoscopy, aiming to reduce the rate of interval cancers related to missed lesions during colonoscopy. Quality indicators are divided into 3 time periods: preprocedure, intraprocedure, and postprocedure. The main pre-procedural indicators are the assessment of the appropriateness of indication of colonoscopy and the prescription of adequate bowel preparation during a consultation prior to colonoscopy. Per-procedural criteria include all technical aspects of the procedure, which are "endoscopist-dependent" factors, particularly cecal intubation, detection of adenomas and withdrawal time. The main post-procedure indicators are the rate of complications, patient experience and optimal surveillance intervals following removal of colorectal polyps. The implementation of key performance measures in endoscopy practice is increasingly important as it can help improving our care of patients and optimize outcomes. In this review, the "Club d'endoscopie digestive" (CED) presented a summary of the main colonoscopy quality indicators, and suggested recommendations that took into account the particularities of our local conditions.
Topics: Adenoma; Cecum; Colonoscopy; Humans; Mass Screening
PubMed: 35288895
DOI: No ID Found -
World Journal of Gastroenterology Sep 2021The serrated pathway accounts for 30%-35% of colorectal cancer (CRC). Unlike hyperplastic polyps, both sessile serrated lesions (SSLs) and traditional serrated adenomas...
The serrated pathway accounts for 30%-35% of colorectal cancer (CRC). Unlike hyperplastic polyps, both sessile serrated lesions (SSLs) and traditional serrated adenomas are premalignant lesions, yet SSLs are considered to be the principal serrated precursor of CRCs. Serrated lesions represent a challenge in detection, classification, and removal-contributing to post-colonoscopy cancer. Therefore, it is of the utmost importance to characterize these lesions properly to ensure complete removal. A retrospective cohort study developed a diagnostic scoring system for SSLs to facilitate their detection endoscopically and subsequent removal. From the study, it can be ascertained that both indistinct border and mucus cap are essential in both recognizing and diagnosing serrated lesions. The proximal colon poses technical challenges for some endoscopists, which is why high-quality colonoscopy plays such an important role. The indistinct border of some SSLs poses another challenge due to difficult complete resection. Overall, it is imperative that gastroenterologists use the key features of mucus cap, indistinct borders, and size of at least five millimeters along with a high-quality colonoscopy and a good bowel preparation to improve the SSL detection rate.
Topics: Adenoma; Colonoscopy; Colorectal Neoplasms; Humans; Retrospective Studies
PubMed: 34629791
DOI: 10.3748/wjg.v27.i34.5625 -
Annals of Oncology : Official Journal... Jun 2017Colorectal adenomas are known as precursors for the majority of colorectal carcinomas. While weight gain during adulthood has been identified as a risk factor for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Colorectal adenomas are known as precursors for the majority of colorectal carcinomas. While weight gain during adulthood has been identified as a risk factor for colorectal cancer, the association is less clear for colorectal adenomas. We conducted a systematic review and meta-analysis to quantify the evidence on this association.
METHODS
We searched Medline up to September 2016 to identify observational (prospective, cross-sectional and retrospective) studies on weight gain during adulthood and colorectal adenoma occurrence and recurrence. We conducted meta-analysis on high weight gain versus stable weight, linear and non-linear dose-response meta-analyses to analyze the association. Summary odds ratios (OR) and 95% confidence intervals (95% CI) were estimated using a random effects model.
RESULTS
For colorectal adenoma occurrence, the summary OR was 1.39 (95% CI: 1.17-1.65; I2: 43%, N = 9 studies, cases = 5507) comparing high (midpoint: 17.4 kg) versus stable weight gain during adulthood and with each 5 kg weight gain the odds increased by 7% (2%-11%; I2: 65%, N = 7 studies). Although there was indication of non-linearity (Pnon-linearity < 0.001) there was an increased odds of colorectal adenoma throughout the whole range of weight gain. Three studies were identified investigating the association between weight gain and colorectal adenoma recurrence and data were limited to draw firm conclusions.
CONCLUSIONS
Even a small amount of adult weight gain was related to a higher odds of colorectal adenoma occurrence. Our findings add to the benefits of weight control in adulthood regarding colorectal adenoma occurrence, which might be relevant for early prevention of colorectal cancer.
Topics: Adenoma; Adult; Colorectal Neoplasms; Female; Humans; Male; Middle Aged; Weight Gain
PubMed: 28327995
DOI: 10.1093/annonc/mdx080 -
Clinical Gastroenterology and... Jun 2023Effects of linked-color imaging (LCI) on colorectal lesion detection and colonoscopy quality remain controversial. This study compared the detection rates of adenoma and... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND & AIMS
Effects of linked-color imaging (LCI) on colorectal lesion detection and colonoscopy quality remain controversial. This study compared the detection rates of adenoma and other precursor lesions using LCI vs white-light imaging (WLI) during screening, diagnostic, and surveillance colonoscopies.
METHODS
This randomized controlled trial was performed at 11 institutions in 4 Asian countries/regions. Patients with abdominal symptoms, a primary screening colonoscopy, positive fecal immunochemical test results, or undergoing postpolypectomy surveillance were recruited and randomly assigned in a 1:1 ratio to either the LCI or high-definition WLI group. The primary outcome was adenoma detection rate (ADR). Secondary outcomes were polyp detection rate, advanced ADR, sessile serrated lesion (SSL) detection rate, and the mean number of adenomas per colonoscopy. The recommended surveillance schedule distribution after trial colonoscopy was analyzed.
RESULTS
Between November 2020 and January 2022, there were 3050 participants (LCI, n = 1527; WLI, n = 1523) recruited. The LCI group ADR was significantly higher than the WLI group ADR using intention-to-treat (58.7% vs 46.7%; P < .01) and per-protocol analyses (59.6% vs 46.4%; P < .01). The LCI group polyp detection rates (68.6% vs 59.5%; P < .01), SSL detection rates (4.8% vs 2.8%; P < .01), and adenomas per colonoscopy (1.48 vs 1.02; P < .01) also were significantly higher. However, the advanced ADR was not significantly different (13.2% vs 11.0%; P = .06). Significantly more patients in the LCI group had shorter recommended surveillance schedules than the WLI group (P < .01).
CONCLUSIONS
Compared with WLI, LCI improved adenoma and other polyp detection rates, including SSLs, resulting in alteration of the recommended surveillance schedule after screening, diagnostic, and postpolypectomy surveillance colonoscopies.
TRIAL REGISTRATION NUMBER
UMIN000042432 (https://www.umin.ac.jp/ctr/index.htm).
Topics: Humans; Colorectal Neoplasms; Colonoscopy; Adenoma; Polyps; Diagnostic Imaging; Colonic Polyps
PubMed: 36328306
DOI: 10.1016/j.cgh.2022.10.021 -
Cancer Journal (Sudbury, Mass.) 2014The trillions of bacteria that naturally reside in the human gut collectively constitute the complex system known the gut microbiome, a vital player for the host's... (Review)
Review
The trillions of bacteria that naturally reside in the human gut collectively constitute the complex system known the gut microbiome, a vital player for the host's homeostasis and health. However, there is mounting evidence that dysbiosis, a state of pathological imbalance in the gut microbiome is present in many disease states. In this review, we present recent insights concerning the gut microbiome's contribution to the development of colorectal adenomas and the subsequent progression to colorectal cancer (CRC). In the United States alone, CRC is the second leading cause of cancer deaths. As a result, there is a high interest in identifying risk factors for adenomas, which are intermediate precursors to CRC. Recent research on CRC and the microbiome suggest that modulation of the gut bacterial composition and structure may be useful in preventing adenomas and CRC. We highlight the known risk factors for colorectal adenomas and the potential mechanisms by which microbial dysbiosis may contribute to the etiology of CRC. We also underscore novel findings from recent studies on the gut microbiota and colorectal adenomas along with current knowledge gaps. Understanding the microbiome may provide promising new directions towards novel diagnostic tools, biomarkers, and therapeutic interventions for CRC.
Topics: Adenoma; Animals; Colorectal Neoplasms; Humans; Microbiota; Risk Factors
PubMed: 24855012
DOI: 10.1097/PPO.0000000000000050