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1,430 result(s) for "Precancerous Conditions - diagnosis"
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Multitarget Stool DNA Testing for Colorectal-Cancer Screening
A stool test that measures mutant KRAS, abnormal gene methylation, and hemoglobin detected significantly more colorectal cancers than a commercial fecal immunochemical test (FIT) but had more false positive results. Colorectal cancer is a major cause of death and disease among men and women in the United States. 1 The underlying neoplastic processes of colorectal carcinogenesis lend themselves to screening. 2 Evidence supports and guidelines endorse several tests and strategies, 3 – 5 and screening for colorectal cancer has been found to be cost-effective. 5 – 7 Despite the supporting evidence, recommendations, and availability of several screening tests, a substantial proportion of the U.S. population is not up to date with screening. 8 A simple, noninvasive test with high sensitivity for both colorectal cancer and advanced precancerous lesions might increase uptake and adherence rates, which could improve . . .
Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial
We evaluated the efficacy of the human papillomavirus HPV-16/18 AS04-adjuvanted vaccine against non-vaccine oncogenic HPV types in the end-of-study analysis after 4 years of follow-up in PATRICIA (PApilloma TRIal against Cancer In young Adults). Healthy women aged 15–25 years with no more than six lifetime sexual partners were included in PATRICIA irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to HPV-16/18 vaccine or a control hepatitis A vaccine, via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites. The study was double-blind. The primary endpoint of PATRICIA has been reported previously; the present analysis evaluates cross-protective vaccine efficacy against non-vaccine oncogenic HPV types in the end-of-study analysis. Analyses were done for three cohorts: the according-to-protocol cohort for efficacy (ATP-E; vaccine n=8067, control n=8047), total vaccinated HPV-naive cohort (TVC-naive; no evidence of infection with 14 oncogenic HPV types at baseline, approximating young adolescents before sexual debut; vaccine n=5824, control n=5820), and the total vaccinated cohort (TVC; all women who received at least one vaccine dose, approximating catch-up populations that include sexually active women; vaccine n=9319, control=9325). Vaccine efficacy was evaluated against 6-month persistent infection, cervical intraepithelial neoplasia grade 2 or greater (CIN2+) associated with 12 non-vaccine HPV types (individually or as composite endpoints), and CIN3+ associated with the composite of 12 non-vaccine HPV types. This study is registered with ClinicalTrials.gov, number NCT00122681. Consistent vaccine efficacy against persistent infection and CIN2+ (with or without HPV-16/18 co-infection) was seen across cohorts for HPV-33, HPV-31, HPV-45, and HPV-51. In the most conservative analysis of vaccine efficacy against CIN2+, where all cases co-infected with HPV-16/18 were removed, vaccine efficacy was noted for HPV-33 in all cohorts, and for HPV-31 in the ATP-E and TVC-naive. Vaccine efficacy against CIN2+ associated with the composite of 12 non-vaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), with or without HPV-16/18 co-infection, was 46·8% (95% CI 30·7–59·4) in the ATP-E, 56·2% (37·2–69·9) in the TVC-naive, and 34·2% (20·4–45·8) in the TVC. Corresponding values for CIN3+ were 73·8% (48·3–87·9), 91·4% (65·0–99·0), and 47·5% (22·8–64·8). Data from the end-of-study analysis of PATRICIA show cross-protective efficacy of the HPV-16/18 vaccine against four oncogenic non-vaccine HPV types—HPV-33, HPV-31, HPV-45, and HPV-51—in different trial cohorts representing diverse groups of women. GlaxoSmithKline Biologicals.
Calcium and vitamin D supplementation and increased risk of serrated polyps: results from a randomised clinical trial
ObjectiveSerrated lesions such as sessile serrated adenomas or polyps (SSA/Ps) are important colorectal cancer precursors, but aetiological factors for these lesions are largely unknown. We aimed to determine the effects of calcium and vitamin D supplementation on the incidence of serrated polyps (SPs) in general and hyperplastic polyps and SSA/Ps specifically.DesignParticipants with one or more adenoma at baseline were randomised to receive 1200 mg/day of elemental calcium, 1000 IU/day of vitamin D3, both or neither agent. Treatment continued for 3 or 5 years, when risk of polyps was determined from surveillance colonoscopy (treatment phase). Outcomes after treatment ceased were also assessed (observational phase). Adjusted risk ratios (aRRs) of SPs were determined via multivariable generalised linear models.ResultsSPs were diagnosed in 565 of 2058 (27.5%) participants during the treatment phase and 329/1108 (29.7%) during the observational phase. In total, 211 SSA/Ps were identified during follow-up. In the treatment phase, there was no effect of either calcium or vitamin D on incidence of SSA/Ps. However, during the later observational phase, we observed elevated risks of SSA/Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).ConclusionIn a large multicentre chemoprevention study, we found evidence that calcium and vitamin D supplementation increased the risk of SSA/Ps. This appeared to be a late effect: 6–10 years after supplementation began. These possible risks must be weighed against the benefits of calcium and vitamin D supplementation. Trial registration number NCT00153816; Results.
A Randomized Crossover Trial of Conventional vs Virtual Chromoendoscopy for Colitis Surveillance: Dysplasia Detection, Feasibility, and Patient Acceptability (CONVINCE)
Abstract Background Chromoendoscopy (CE) is the recommended surveillance technique for colitis, but uptake has been limited and the literature provides scant information on patient experience (PE); imperative to adherence to surveillance programmes. Virtual CE (VCE) by Fujinon Intelligent Colour Enhancement digitally reconstructs mucosal images in real time, without the technical challenges of CE. We performed a multifaceted randomized crossover trial (RCT) to evaluate study feasibility and obtain preliminary comparative procedural and PE data. Methods Patients were randomized to undergo either CE with indigo carmine or VCE as the first procedure. After 3-8 weeks, participants underwent colonoscopy with the second technique. Patient recruitment/retention, missed dysplasia, prediction of dysplasia, and contamination (memory/sampling of the first procedure) were recorded. PE was assessed by validated questionnaires, and pain was assessed using a visual analog scale (mm). Results Sixty patients were recruited, and 48 patients (first procedure: 23 VCE, 25 CE) completed the trial (retention 80%) with no episodes of contamination. Eleven dysplastic lesions were detected in n = 7/48 (14.5%). VCE missed 1 lesion, and CE missed 2 lesions in n = 2 (data of VCE vs CE, respectively, for dysplasia diagnostic accuracy: 93.94% [85.2%-98.32%] vs 76.9% [66.9%-98.2%]; examination time [minutes]: 14 +/- 4 vs 20 +/- 7 (95% confidence interval, 3.5 to 8; P < 0.001); pain (mm): 27.4 +/- 17.5 vs 34.7 +/- 18; patient preference: 67% [n = 31] vs 33% [n = 15] in n = 46; P < 0.001). Conclusions This is the first RCT to include validated PE in a colitis surveillance program. VCE is safe, technically easier, quicker, and more comfortable test, with dysplasia detection at least as good as that of CE, overcoming many barriers to the wider adoption of CE. This trial may serve as a successful foundation for a a multicenter trial to confirm the value of VCE for colitis surveillance.
CT-Colonography vs. Colonoscopy for Detection of High-Risk Sessile Serrated Polyps
Sessile serrated polyps (SSPs) are suggested to be the precursors of 15-30% of all colorectal cancers (CRCs). Therefore, CRC screening modalities should also be designed to detect high-risk SSPs. We compared computed tomography colonography (CTC) with colonoscopy-based screening for the detection of high-risk SSPs in average-risk individuals. Data from a randomized controlled trial that compared CTC with colonoscopy for population screening were used for the analysis. Individuals diagnosed at CTC with a lesion ≥10 mm in size were referred for colonoscopy. Individuals with only 6-9 mm lesions were offered surveillance CTC. This surveillance CTC was followed by a colonoscopy when a lesion ≥6 mm was detected. Yield of both was accumulated to mimic current American College of Radiology CTC referral strategy (referral of individuals with any lesion ≥6 mm). Per participant detection of ≥1 high-risk (dysplastic and/or ≥10 mm) SSP was compared with colonoscopy using multiple logistic regression analysis. In total, 8,844 individuals were invited to participate (in 2:1 allocation), of which 1,276 colonoscopy and 982 CTC invitees participated in the study. In the colonoscopy arm, 4.3% of individuals were diagnosed with ≥1 high-risk SSP, compared with 0.8% in the CTC arm (odds ratio (OR) 5.5; 95% confidence interval (CI) 2.6-11.6; P<0.001). In total, 3.1% of individuals in the colonoscopy arm were diagnosed with high-risk SSPs as most advanced lesion, compared with 0.4% in the CTC arm (OR 7.7; 95% CI 2.7-21.6; P<0.001). The current CTC strategy showed a marked lower detection for especially flat high-risk SSPs (17 vs. 0), high-risk SSP located in the proximal colon (32 vs. 1), and SSPs with dysplasia (30 vs. 1). In a randomized controlled setting, the detection rate of high-risk SSPs was significantly higher with colonoscopy than CTC. These results might have implications for CTC as a CRC modality for opportunistic screening in average-risk adults.
Risk factors of precancerous cervical lesions: The role of women’s socio-demographic, sexual behavior and body mass index in Amhara region referral hospitals; case-control study
Cervical cancer remains one of the major public health challenges in low and middle-income countries including Ethiopia. There was a scarce of evidence regarding the effect of woman's socio-demographic characteristics and body mass index on the development of precancerous cervical lesions in Ethiopia. Therefore, the current study aimed at identifying the risk factors of precancerous cervical lesions among women visiting referral hospitals for cervical cancer screening in Amhara national regional state. A hospital-based case-control study was conducted from 22 December 2019 to 8 April 2020 among 200 women including 67 visual inspections with acetic acid (VIA) positive women (i.e., cases) and 133 visual inspections with acetic acid (VIA) negative women (i.e., controls). The study was conducted at randomly selected referral hospitals in Amhara national regional state. Data were collected mainly through face to face interview and chart review using structured questionnaire and checklist respectively. Data were then entered to EpiData version 4.6 and exported to SPSS version 25 for analysis. Binary logistic regression model was fitted and variables with p-value of < 0.2 at bivariable logistic regression analysis were candidates for the multivariable analysis. Level of significance was claimed based on adjusted odds ratio (AOR) with 95% confidence interval (CI) at p-value of ≤ 0.05. This study illustrates that the odds of being positive for precancerous cervical lesion (PCL) were higher among women who had body mass index (BMI) of <18.5 kg/m2 (AOR = 3.83; 95% CI: 1.26, 8.76), early coitarche (AOR = 3.15; 95% CI: 1.50, 11.49, history of using oral contraceptive pills (AOR = 2.74; 95% CI: 1.6, 7.4), lifetime sexual transmitted infections (AOR = 3.73; 95% CI: 2.5, 12.28) and multiple sexual partners (AOR = 3.23; 95% CI: 1.82, 9.29). On the other hand, participants' BMI of ≥25 kg/m2 (AOR = 0.46; 95% CI: 0.36, 0.75) and level of education of college and above (AOR = 0.29; 95% CI: 0.23, 0.77) were identified to be protective factors of PCL. Most of the determinants of precancerous cervical lesions were modifiable and mainly related to women's socio-demographic characteristics, sexual behaviors and body mass index. Therefore, strengthening awareness on safe sexual practices and healthy life styles through information, education and communication (IEC), and behavioral change communication (BCC) would decrease the incidence of precancerous cervical lesions.
Simultaneous Recognition of Atrophic Gastritis and Intestinal Metaplasia on White Light Endoscopic Images Based on Convolutional Neural Networks: A Multicenter Study
Patients with atrophic gastritis (AG) or gastric intestinal metaplasia (GIM) have elevated risk of gastric adenocarcinoma. Endoscopic screening and surveillance have been implemented in high incidence countries. The study aimed to evaluate the accuracy of a deep convolutional neural network (CNN) for simultaneous recognition of AG and GIM. Archived endoscopic white light images with corresponding gastric biopsies were collected from 14 hospitals located in different regions of China. Corresponding images by anatomic sites containing AG, GIM, and chronic non-AG were categorized using pathology reports. The participants were randomly assigned (8:1:1) to the training cohort for developing the CNN model (TResNet), the validation cohort for fine-tuning, and the test cohort for evaluating the diagnostic accuracy. The area under the curve (AUC), sensitivity, specificity, and accuracy with 95% confidence interval (CI) were calculated. A total of 7,037 endoscopic images from 2,741 participants were used to develop the CNN for recognition of AG and/or GIM. The AUC for recognizing AG was 0.98 (95% CI 0.97-0.99) with sensitivity, specificity, and accuracy of 96.2% (95% CI 94.2%-97.6%), 96.4% (95% CI 94.8%-97.9%), and 96.4% (95% CI 94.4%-97.8%), respectively. The AUC for recognizing GIM was 0.99 (95% CI 0.98-1.00) with sensitivity, specificity, and accuracy of 97.9% (95% CI 96.2%-98.9%), 97.5% (95% CI 95.8%-98.6%), and 97.6% (95% CI 95.8%-98.6%), respectively. CNN using endoscopic white light images achieved high diagnostic accuracy in recognizing AG and GIM.
Pilot study of cytological testing for oesophageal squamous cell dysplasia in a high-risk area in Northern Iran
Background: Oesophageal squamous cell carcinoma (ESCC) is a fatal disease with 5-year survival rates of <5% in Northern Iran. Oesophageal squamous dysplasia (ESD) is the precursor histologic lesion of ESCC. This pilot study was conducted to assess the feasibility, safety, and acceptability of non-endoscopic cytological examination of the oesophagus and to provide initial data on the accuracy of cytological atypia for identifying patients with ESD in this very-high-risk area. Methods: Randomly selected asymptomatic participants of the Golestan Cohort Study were recruited. A cytological specimen was taken using a capsule sponge device and evaluated for atypical cells. Sections of the cytological specimen were also stained for p53 protein. Patient acceptability was assessed using a visual analogue scale. The cytological diagnosis was compared with a chromoendoscopic examination using Lugol’s solution. Results: Three hundred and forty-four subjects (43% male, mean (s.d.) age 55.6 (7.9) years) were referred to the study clinic. Three hundred and twelve met eligibility criteria and consented, of which 301 subjects (96.5%) completed both cytological and endoscopic examinations. There were no complications. Most of the participants (279; 92.7%) were satisfied with the examination. The sensitivity and specificity of the cytological examination for identifying subjects with high-grade ESD were 100 and 97%, respectively. We found an accuracy of 100% (95% CI=99–100%) for a combination of cytological examination and p53 staining to detect high-grade ESD. Conclusions: The capsule sponge methodology seems to be a feasible, safe, and acceptable method for diagnosing precancerous lesions of the oesophagus in this population, with promising initial accuracy data for the detection of high-grade ESD.
Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial
IntroductionThe follow-up adherence after treatment for a positive screening test is critical for preventing the development of screen‐detected abnormalities in cervical cancer. Yet, this poses a major challenge in developing countries like Ethiopia, emphasising the urgency for intervention strategies. Our trial aims to assess which strategies would be effective in improving adherence to follow-up after suspicious cervical lesion treatment in Ethiopia. Thus, the objective of this study is to evaluate key interventions to improve the follow-up adherence rate among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia.Method and analysisWe will employ a pragmatic randomised control trial study design, using Consolidated Standards of Reporting Trials guidelines for reporting and a Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for developing the protocol, to evaluate intervention effectiveness. These interventions are: (a) structured nurses-led telephone call reminders, (b) home-visit reminders led by health extension workers and (c) application-based automated short message service text reminders. The standard care involves only receiving oral follow-up advice and a baseline follow-up card. The planned start date is 1 November 2024, with an anticipated end date of 1 November 2025. Our study will include women aged 30–49 who are HIV-negative and those over 25 who are HIV-positive, and who have been treated for suspicious cervical lesions after a positive visual inspection with acetic acid (VIA) screening, as per Ethiopian Ministry of Health guidelines for cervical cancer screening eligibility. The required sample size is 460, with 115 participants per arm. Study participants in the intervention group will receive the stated interventions plus the standard care, while the control group will receive only the standard care. The interventions will be delivered three times annually: 4 months from baseline, then at 8 months and finally at 12 months before the appointment due date. The primary outcome of our study is the proportion of adherence to follow-up recommendations, which will be measured by rescreening (VIA) after 1 year (11–13 months after the first screening). Descriptive statistics, χ2 test (Fisher’s exact test), binary logistic regression analysis and intention-to-treat will be used to describe and interpret the results.Ethics and disseminationThe trial protocol has been approved by the institutional review board of Addis Ababa University with protocol number (008/24/SPH). Trial results will be disseminated to study participants, national and international audiences through workshops, conferences and publications in reputable journals.Trial registration number NCT06515301.
Use of pronase in screening for early cancers of the upper gastrointestinal tract
This study aimed to investigate the effectiveness of pronase in improving the detection rate of early cancer and enhancing visual field clarity during gastroscopy in China. In total, 1450 patients who participated in an early diagnosis and treatment programme of upper gastrointestinal cancer in Wuwei, Gansu Province between 2020 and 2021 were enrolled. Cluster randomisation was utilised at the community level. All patients underwent endoscopy and biopsy. The experimental group (n=725) received pronase granules and dimethicone prior to gastroscopy; the control group (n=725) received dimethicone alone. Endoscopic visibility scores, examination durations, and lesion detection rates were recorded for both groups. Visibility scores for all regions of the stomach were significantly lower in the experimental group than in the control group (P<0.001). This finding remained consistent after adjustment for confounding factors in multiple linear regression analysis. The detection rate of precancerous lesions and early cancer was significantly higher in the experimental group than in the control group (77.5% vs 62.5%; P<0.001). Binary logistic regression analysis indicated that the likelihood of detecting early cancer was greater in the experimental group, with an odds ratio of 3.840 (95% confidence interval=1.204-12.241; P=0.023). Also, average gastroscopy time was significantly shorter in the experimental group than in the control group (6.52±2.51 min vs 10.03±1.23 min, =33.81; P=0.001). The administration of pronase prior to gastroscopy enhances visual field clarity, reduces examination time, and increases the detection rates of precancerous lesions and early cancer.