Clinical validation of a ctDNA-Based Assay for Multi-Cancer Detection: An Interim Report from a Vietnamese Longitudinal Prospective Cohort Study of 2795 Participants

Nguyen, Thi Hue Hanh; Lu, Y-Thanh; Le, Van Hoi; Bui, Vinh; Nguyen, Lan Hieu; Pham, Nhu Hiep; Phan, Thanh Hai; Nguyen, Hung; Tran, Van Song; Bui, Chi Viet; Vo, Van Kha; Nguyen, Nhan P.T.; Dang, Ha Huu Phuoc; Pham, Van Dung; Cao, Van Thinh; Nguyen, Thanh-Binh; Nguyen, Luu Hong Dang; Hong, Phan Ngoc; Nguyễn, Trọng Nghĩa; Nguyen, Thien Chi Van; Pham, Thi Mong Quynh; Tran, Vu Uyen; Le, Minh-Tri; Vo, Dac Ho; Tran, Thi Minh Thu; Nguyen, Minh Nguyen; Nguyễn, Thị Thanh Bình; Tieu, Ba Linh; Nguyen, Huu Tam Phuc; Truong, Dinh Yen An; Cao, Chi Thuy Tien; Nguyen, Van Tung; Le, Thi Minh Hue; Le, Quyen; Luong, Thi Lan Anh; Doan, Thi Kim Phuong; Dao, Thi Trang; Phan, Canh Duy; Nguyễn, Thanh Xuân; Phạm, Ngọc Hiếu; Nguyen, Bao Toan; Pham, Thi Thu Thuy; Le, Huu Linh; Truong, Cong Thanh; Jasmine, Thanh Xuan; Le, Minh Chi; Phan, Van Bau; Truong, Quang Binh; Tran, Thi Huong Ly; Huynh, Minh Thien; Tran, Tu Quy; Nguyen, Si Tuan; Tran, Van Khanh; Nguyen, Huu Nguyen; Nguyen, Duy; Phan, Thi Van; Do, Thanh-Thuy Thi; Truong, Dinh-Kiet; Tang, Hung Sang; Phan, Minh-Duy; Giang, Hoa; Nguyen, Hoa; Tran, Le Son

doi:10.1080/07357907.2023.2173773

Cited by 20 publications

(24 citation statements)

References 42 publications

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“…Most (66.58%) participants were aged between 25-44 years, while the least proportion (1.61%) were aged above 65 years. In general, these data are similar to other KAP studies carried out elsewhere, most respondents claimed to belong to age groups of young people and young adults [15][16][17][18][19][20][21] . The majority (62.33%) of the participants were not married.…”

Section: Demographic Characteristics Of Study Participantssupporting

confidence: 88%

The level of Knowledge, Attitudes, and Practices concerning Covid-19 Vaccination and their Determinants in Chittagong District (Bangladesh)

Akter

Bajinka

faria

et al. 2022

Preprint

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Background: Bangladesh has not previously experienced epidemics such as SARS or MERS, and it is clear that its public healthcare systems are not readily prepared for COVID-19 vaccine uptake. Objective: The aim of this research was to evaluate the level of knowledge, attitudes, and practices concerning COVID-19 vaccination and their determinants in Chittagong District, Bangladesh. Methods: This descriptive cross-sectional study was conducted in Chittagong, Bangladesh, from October 2021 to April 2022. A study of 2,882 men and women who had been vaccinated with the COVID-19 vaccine and those who had not been vaccinated was conducted in Chittagong, Bangladesh. A purposeful sampling method was used in this study. The data was collected using a standardized pretested questionnaire. Results: A total of 850 men and women’s information was obtained, of which Group A = 205 (24.12%) for men and women who had been vaccinated, and Group B = 645 (75.88%) for men and women who had not been vaccinated. There were group/independent variables that entered the equation for subgroup analysis. Sensitivity analysis showed that the majority of the men and women that had been vaccinated had a good level of knowledge, attitudes, and practices regarding COVID-19 vaccination with (OR=0.166, 95% CI: 0. 113~0.245) and (OR=0.191, 95% CI: 0. 113~0.245), respectively. In addition, most of the men and women that were unvaccinated had poor/bad level of knowledge, attitudes, and practices regarding COVID-19 vaccination with (OR=0.228, 95% CI: 0.154~0.336) and (OR=0.239, 95% CI: 0.154~0.336), respectively. Most of the participants were aged between 40-49 years. The majority of the participants were Muslims, had secondary school level of education, and were employed. Conclusion: The results suggest that the epidemic has significantly increased the level of knowledge, attitudes, and practices concerning COVID-19 vaccination. In addition, the factors affecting the level of knowledge, attitudes, and practices concerning COVID-19 vaccination are different. This means that relevant pro-vaccination promotion strategies are needed to ensure the safety of the people during the epidemic. Under the normalization of the epidemic situation, the local area should optimize public health education, allocate medical resources rationally, and avoid ignoring the routine COVID-19 vaccination for effective and efficient prevention and control of the rapid spread of the COVID-19 epidemic.

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Section: Demographic Characteristics Of Study Participantssupporting

confidence: 88%

The level of Knowledge, Attitudes, and Practices concerning Covid-19 Vaccination and their Determinants in Chittagong District (Bangladesh)

Akter

Bajinka

faria

et al. 2022

Preprint

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“…It has been well established that blood hemolysis causes genomic DNA (gDNA) and hemoglobin contamination which could interfere with the performance of liquid biopsy tests 26 . To assess the impact of these two potential interferents, we generated 30 pooled plasma samples, including cancer (N=20) and healthy control (N=10).…”

Section: Resultsmentioning

confidence: 99%

Analytical and clinical validation of a circulating tumor DNA-based assay for multi-cancer early detection

Dang Nguyen,

Hanh Nguyen,

et al. 2023

Preprint

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The development of multi-cancer early detection (MCED) through a single blood test has emerged as a promising method for improving the efficiency of early cancer detection and benefiting population health. However, the lack of analytical validation and clinical evidence for their utility in diverse populations have prevented their use in clinical practice. To address these challenges, we conducted a comprehensive analytical and clinical validation for an MCED test, SPOT-MAS (Screening for the Presence Of Tumor by DNA Methylation And Size). The analytical validation was to establish the limit of detection, reproducibility of test results and assess the impact of potential interferents on test performance. Specifically, SPOT-MAS could detect at least 50% of cancer samples at a specificity of 98% if the samples have tumor fraction more than 0.049 (95% CI: 0.043-0.059). The results were consistently reproduced for both intra- and inter-batch analysis. Moreover, our test remained robust at hemoglobin contamination of 500 mg/dl and genomic DNA contamination of up to 100%. To validate the performance of SPOT-MAS test in clinical settings, we launched a multi-center prospective trial, named K-DETEK, of 10,027 asymptomatic participants in Vietnam. Our assay achieved a positive predictive value of 58.14% (95%CI: 43.33-71.62) with 84.00% (95%CI: 65.35-93.60) accuracy in predicting tumor location and a negative predictive value of 99.92% (95%CI: 99.83-99.96). To our knowledge, this is the first and largest prospective validation study in Asia supporting the utility of SPOT-MAS as a multi-cancer blood test for early detection in a low- and middle-income country, where a nationwide cancer screening program is urgently needed but currently not available.

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“…Lastly, this was a retrospective cohort study and may be biased by the nature of this study design. In an interim 6-month report of a prospective study named K-DETEK, we were encouraged by the preliminary data demonstrated the ability of SPOT-MAS to detect cancer patients who exhibited no symptoms at the time of testing (59). Despite these promising results, the performance of SPOT-MAS as an early cancer screening test remains to be fully validated in a large, multi-center prospective study with 1 to 2 years of follow up.…”

Section: Discussionmentioning

confidence: 99%

Multimodal analysis of methylomics and fragmentomics in plasma cell-free DNA for multi-cancer early detection and localization

Nguyen¹,

Nguyễn²,

Doan³

et al. 2023

Preprint

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The non-invasive approach for early cancer detection promises a screening assay accessible for everyone. However, the delivery of this promise is limited due mostly to the high sequencing cost associated with available assays. Here, we developed a multimodal assay called SPOT-MAS (Screening for the Presence Of Tumor by Methylation And Size) to simultaneously profile methylomics, fragmentomics, copy number, and end motifs in a single workflow using targeted and shallow genome-wide sequencing of cell-free DNA. We applied SPOT-MAS to 738 nonmetastatic patients with breast, colorectal, gastric, lung and liver cancer, and 1,550 healthy controls. SPOT-MAS detected the five cancer types with a sensitivity of 72.4% and specificity of 97.0%, with AUC of 0.95 (95% CI 0.93-0.96). For tumor-of-origin, a graph convolutional neural network was adopted and could achieve an accuracy of 0.7. In conclusion, our study demonstrates comparable performance to other early cancer detection assays while requiring significantly lower sequencing depth, making it economically feasible for population-wide screening.

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Clinical validation of a ctDNA-Based Assay for Multi-Cancer Detection: An Interim Report from a Vietnamese Longitudinal Prospective Cohort Study of 2795 Participants

Cited by 20 publications

References 42 publications

The level of Knowledge, Attitudes, and Practices concerning Covid-19 Vaccination and their Determinants in Chittagong District (Bangladesh)

The level of Knowledge, Attitudes, and Practices concerning Covid-19 Vaccination and their Determinants in Chittagong District (Bangladesh)

Analytical and clinical validation of a circulating tumor DNA-based assay for multi-cancer early detection

Multimodal analysis of methylomics and fragmentomics in plasma cell-free DNA for multi-cancer early detection and localization

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