Feasibility of the Asia-Pacific colorectal cancer risk score and fecal immunochemical test for colorectal neoplasm screening prioritization in Thailand: A multi-center study
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ABSTRACT:
DISEASE(S): Asia Pacific Colorectal Cancer Risk Score,Fecal Immunochemical Test,Advanced Colorectal Neoplasm,Colonoscopy,Colorectal Cancer Screening
PROVIDER: 2565077 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Interventions: Normal control group:NA;Colorectal adenoma group:NA;Colorectal adenocarcinoma group:NA
Primary outcome(s): Health /CRA classification diagnostic model based on microbial related markers;CRA/CRC classification and diagnosis model based on microbial related markers
Study Design: Cross-sectional
| 37407 | ecrin-mdr-crc
Project description:BackgroundFecal immunochemical tests (FITs) are the most widely used non-invasive tests in colorectal cancer (CRC) screening. However, evidence about the direct comparison of the test performance of the self-administered qualitative a laboratory-based quantitative FITs in a CRC screening setting is sparse.MethodsBased on a CRC screening trial (TARGET-C), we included 3144 pre-colonoscopy fecal samples, including 24 CRCs, 230 advanced adenomas, 622 non-advanced adenomas, and 2268 participants without significant findings at colonoscopy. Three self-administered qualitative FITs (Pupu tube) with positivity thresholds of 8.0, 14.4, or 20.8 μg hemoglobin (Hb)/g preset by the manufacturer and one laboratory-based quantitative FIT (OC-Sensor) with a positivity threshold of 20 μg Hb/g recommended by the manufacturer were tested by trained staff in the central laboratory. The diagnostic performance of the FITs for detecting colorectal neoplasms was compared in the different scenarios using the preset and adjusted thresholds (for the quantitative FIT).ResultsAt the thresholds preset by the manufacturers, apart from the qualitative FIT-3, significantly higher sensitivities for detecting advanced adenoma were observed for the qualitative FIT-1 (33.9% [95% CI: 28.7-39.4%]) and qualitative FIT-2 (22.2% [95% CI: 17.7-27.2%]) compared to the quantitative FIT (11.7% [95% CI: 8.4-15.8%]), while at a cost of significantly lower specificities. However, such difference was not observed for detecting CRC. For scenarios of adjusting the positivity thresholds of the quantitative FIT to yield comparable specificity or comparable positivity rate to the three qualitative FITs accordingly, there were no significant differences in terms of sensitivity, specificity, positive/negative predictive values and positive/negative likelihood ratios for detecting CRC or advanced adenoma between the two types of FITs, which was further evidenced in ROC analysis.ConclusionsAlthough the self-administered qualitative and the laboratory-based quantitative FITs had varied test performance at the positivity thresholds preset by the manufacturer, such heterogeneity could be overcome by adjusting thresholds to yield comparable specificities or positivity rates. Future CRC screening programs should select appropriate types of FITs and define the thresholds based on the targeted specificities and manageable positivity rates.
| S-EPMC8183845 | biostudies-literature
Project description:Interventions: derivation:model development;validation:model testing
Primary outcome(s): prevalence of advanced colorectal neoplasia
Study Design: Cross-sectional
| 2662635 | ecrin-mdr-crc
Project description:To further unravel the potential molecular mechanisms involved in the loss of muscle function during an acute exacerbation, a cross-sectional microarray study was designed to compare the gene expression profile of the vastus lateralis muscle in patients with an acute COPD exacerbation and in stable COPD patients. Keywords: cross-sectional patient study
2009-03-14 | GSE10828 | GEO
Project description:To further unravel the potential molecular mechanisms involved in the loss of muscle function during an acute exacerbation, a cross-sectional microarray study was designed to compare the gene expression profile of the vastus lateralis muscle in patients with an acute COPD exacerbation and in stable COPD patients. Keywords: cross-sectional patient study A cross-sectional microarray study was designed. The microarray screening was performed on a vastus lateralis biopsy obtained from 4 patients with an acute COPD exacerbation and 5 stable COPD patients. No replicates or dye-swaps were included.
2009-03-13 | E-GEOD-10828 | biostudies-arrayexpress
Project description:BackgroundThe primary aim of this study was to compare survival from neoadjuvant chemoradiotherapy plus surgery (NCRS) versus neoadjuvant chemotherapy plus surgery (NCS) for the treatment of esophageal or junctional adenocarcinoma. The secondary aims were to compare pathological effects, short-term mortality and morbidity, and to evaluate the effect of lymph node harvest upon survival in both treatment groups.MethodsData were collected from 10 European centers from 2001 to 2012. Six hundred and eight patients with stage II or III oesophageal or oesophago-gastric junctional adenocarcinoma were included; 301 in the NCRS group and 307 in the NCS group. Propensity score matching and Cox regression analyses were used to compensate for differences in baseline characteristics.ResultsNCRS resulted in significant pathological benefits with more ypT0 (26.7% versus 5%; P < 0.001), more ypN0 (63.3% versus 32.1%; P < 0.001), and reduced R1/2 resection margins (7.7% versus 21.8%; P < 0.001). Analysis of short-term outcomes showed no statistically significant differences in 30-day or 90-day mortality, but increased incidence of anastomotic leak (23.1% versus 6.8%; P < 0.001) in NCRS patients. There were no statistically significant differences between the groups in 3-year overall survival (57.9% versus 53.4%; Hazard Ratio (HR)= 0.89, 95%C.I. 0.67-1.17, P = 0.391) nor disease-free survival (52.9% versus 48.9%; HR = 0.90, 95%C.I. 0.69-1.18, P = 0.443). The pattern of recurrence was also similar (P = 0.660). There was a higher lymph node harvest in the NCS group (27 versus 14; P < 0.001), which was significantly associated with a lower recurrence rate and improved disease free survival within the NCS group.ConclusionThe survival differences between NCRS and NCS maybe modest, if present at all, for the treatment of locally advanced esophageal or junctional adenocarcinoma. Future large-scale randomized trials must control and monitor indicators of the quality of surgery, as the extent of lymphadenectomy appears to influence prognosis in patients treated with NCS, from this large multi-center European study.
| S-EPMC5391716 | biostudies-literature
Project description:To assess the fecal immunochemical test (FIT) accuracy for colorectal cancer (CRC) and advanced neoplasia (AN) detection in CRC screening.We performed a multicentric, prospective, double blind study of diagnostic tests on asymptomatic average-risk individuals submitted to screening colonoscopy. Two stool samples were collected and the fecal hemoglobin concentration was determined in the first sample (FIT1) and the highest level of both samples (FITmax) using the OC-sensor™. Areas under the curve (AUC) for CRC and AN were calculated. The best FIT1 and FITmax cut-off values for CRC were determined. At this threshold, number needed to scope (NNS) to detect a CRC and an AN and the cost per lesion detected were calculated.About 779 individuals were included. An AN was found in 97 (12.5%) individuals: a CRC in 5 (0.6%) and an advanced adenoma (? 10 mm, villous histology or high grade dysplasia) in 92 (11.9%) subjects. For CRC diagnosis, FIT1 AUC was 0.96 (95%CI: 0.95-0.98) and FITmax AUC was 0.95 (95%CI: 0.93-0.97). For AN, FIT1 and FITmax AUC were similar (0.72, 95%CI: 0.66-0.78 vs 0.73, 95%CI: 0.68-0.79, respectively, P = 0.34). Depending on the number of determinations and the positivity threshold cut-off used sensitivity for AN detection ranged between 28% and 42% and specificity between 91% and 97%. At the best cut-off point for CRC detection (115 ng/mL), the NNS to detect a CRC were 10.2 and 15.8; and the cost per CRC was 1814€ and 2985€ on FIT1 and FITmax strategies respectively. At this threshold the sensitivity, NNS and cost per AN detected were 30%, 1.76, and 306€, in FIT1 strategy, and 36%, 2.26€ and 426€, in FITmax strategy, respectively.Performing two tests does not improve diagnostic accuracy, but increases cost and NNS to detect a lesion.
| S-EPMC3921527 | biostudies-literature
Project description:OBJECTIVES:Fecal immunochemical tests (FITs) can efficiently screen for colorectal cancer (CRC), but little is known on the timing to their completion. We investigate the time to return of a FIT following an order and describe patient characteristics associated with FIT return. STUDY DESIGN:Retrospective cohort study. METHODS:We identified 63,478 members of Kaiser Permanente Washington, aged 50 to 74 years, who received a FIT order from 2011 through 2012. Patient characteristics were ascertained through administrative and electronic health record data sources. We compared time from FIT order to return by patient characteristics using Kaplan-Meier and Cox regression methods. RESULTS:About half (53.7%) of members completed a FIT. Median time from order to return was 13 days (mean, 44.5 days; interquartile range, 6-42 days). There was higher completion of FITs among Asian patients (hazard ratio [HR], 1.43; 95% CI, 1.38-1.48), black patients (HR, 1.13; 95% CI, 1.08-1.19), and Hispanic patients (HR, 1.10; 95% CI, 1.04-1.16) compared with white patients; among patients with recent CRC testing (vs no testing in past 2 years; HR, 1.90; 95% CI, 1.86-1.95); and among patients with Medicare insurance (vs commercial; HR, 1.30; 95% CI, 1.24-1.37). Factors associated with decreased FIT completion included younger age (50-54 years vs 70-74 years; HR, 0.87; 95% CI, 0.82-0.92), obesity (vs normal body mass index; HR, 0.88; 95% CI, 0.86-0.91), and higher Charlson Comorbidity Index score (?3 vs 0; HR, 0.82; 95% CI, 0.79-0.87). CONCLUSIONS:Time to return of FIT varies by patient characteristics. We observed greater FIT completion among people of color, suggesting that racial disparities in CRC may not be due to patient completion of the test after an order is received.
| S-EPMC7170013 | biostudies-literature
Project description:Interventions: NA:No
Primary outcome(s): Whole exome;PFS
Study Design: Cross-sectional
| 47576 | ecrin-mdr-crc
Project description:The immunosuppressant drugs (ISDs), tacrolimus and cyclosporine, are vital for solid organ transplant patients to prevent rejection. However, toxicity is a concern, and absorption is highly variable across patients; therefore, ISD levels need to be precisely monitored. In the Asia-Pacific (APAC) region, tacrolimus and cyclosporine concentrations are typically measured using immunoassays. The objective of this study was to assess the analytical performance of Roche Elecsystacrolimus and cyclosporinee electrochemiluminescence immunoassays (ECLIAs).This evaluation was performed in seven centers across China, South Korea, and Malaysia. Imprecision (repeatability and reproducibility), assay accuracy, and lot-to-lot reagent variability were tested. The Elecsys ECLIAs were compared with commercially available immunoassays (Architect, Dimension, and Viva-E systems) using whole blood samples from patients with various transplant types (kidney, liver, heart, and bone marrow).Coefficients of variation for repeatability and reproducibility were ?5.4% and ?12.4%, respectively, for the tacrolimus ECLIA, and ?5.1% and ?7.3%, respectively, for the cyclosporine ECLIA. Method comparisons of the tacrolimus ECLIA with Architect, Dimension, and Viva-E systems yielded slope values of 1.01, 1.14, and 0.897, respectively. The cyclosporine ECLIA showed even closer agreements with the Architect, Dimension, and Viva-E systems (slope values of 1.04, 1.04, and 1.09, respectively). No major differences were observed among the different transplant types.The tacrolimus and cyclosporine ECLIAs demonstrated excellent precision and close agreement with other immunoassays tested. These results show that both assays are suitable for ISD monitoring in an APAC population across a range of different transplant types.
| S-EPMC5736684 | biostudies-other