Background Prostate cancer is one of the most common malignant tumors and poses a substantial threat to human health. PSA or enhanced MRI is widely used in prostate cancer screening or diagnosis. However, false-positive PSA or enhanced MRI results can lead to misdiagnosis and incorrect puncture biopsy, while false-negative PSA or enhanced MRI results can lead to missed diagnosis and delayed treatment. There is an urgent need to find convenient, economical and non-invasive diagnostic methods to reduce the PSA or enhanced MRI false-negative and false-positive rates. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in prostate cancer. Patients and methods The study finally included 464 subjects with positive PSA test (prostate cancer group, n=292; BPH group, n=172). Remaining serum samples from the subjects were collected and tested with YiDiXie™ all-cancer detection kit. The sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D were evaluated respectively. Results The sensitivity of YiDiXie™-SS was 100% (95% CI: 98.7% - 100%) and its specificity was 60.5% (95% CI: 53.0% - 67.5%). This means that YiDiXie™-SS has an extremely high sensitivity and relatively high specificity in prostate tumors.YiDiXie™-HS has a sensitivity of 93.8% (95% CI: 90.5% - 96.1%) and a specificity of 86.0% (95% CI: 80.1% - 90.4%). This means that YiDiXie™ -HS has high sensitivity and specificity in prostate tumors.YiDiXie™-D has a sensitivity of 80.8% (95% CI: 75.9% - 84.9%) and a specificity of 93.0% (95% CI: 88.2% - 96.0%). This means that YiDiXie™-D has relatively high sensitivity and very high specificity in prostate tumors.YiDiXie™-SS had a sensitivity of 100% (95% CI: 98.6% - 100%), 100% (95% CI: 97.6% - 100%) and specificity of 57.7% (95% CI: 49.8% - 65.2%), 59.6% (95% CI. 49.5% - 68.9%). This means that the application of YiDiXie™-SS reduced the false positive rate of PSA and enhanced MRI by 57.7% (95% CI: 49.8% - 65.2%), 59.6% (95% CI: 49.5% - 68.9%), respectively, with essentially no increase in the underdiagnosis of malignant tumors.YiDiXie™-HS had a sensitivity of 92.3% (95% CI: 66.7% - 99.6%), 90.2% (95% CI: 79.0% - 95.7%), and specificity of 81.3% (95% CI: 57.0% - 93.4%), 83.3% (95% CI : 55.2% - 97.0%),respectively. This means that the application of YiDiXie™-HS reduced the false-negative rate of PSA and enhanced MRI by 92.3% (95% CI: 66.7% - 99.6%), 90.2% (95% CI: 79.0% - 95.7%), respectively.The sensitivity of YiDiXie™-D in PSA and enhanced MRI positive patients was 81.0% (95% CI: 76.0% - 85.2%), 83.6% (95% CI: 77.1% - 88.6%), respectively, and its specificity was 92.9% (95% CI: 87.8% - 96.0%), 92.6% (95% CI : 85.4% - 96.3%), respectively. This means that YiDiXie™-D reduced PSA and enhanced MRI false positive rates by 92.9% (95% CI: 87.8% - 96.0%), 92.6% (95% CI: 85.4% - 96.3%), respectively.YiDiXie™-D had a sensitivity of 76.9% (95% CI: 49.7% - 91.8%) and 76.5% (95% CI: 63.2% - 86.0%) in PSA- and enhanced MRI-negative patients, respectively, and its specificity was 93.8% (95% CI: 71.7% - 99.7%) and 83.3% (95% CI : 55.2% - 97.0%), respectively. This means that YiDiXie™-D reduced PSA and enhanced MRI false-negative rates by 76.9% (95% CI: 49.7% - 91.8%) and 76.5% (95% CI: 63.2% - 86.0%), respectively, while maintaining a high specificity.. Conclusion YiDiXie™-SS has very high sensitivity and relatively high specificity in prostate tumors.YiDiXie™-HS has high sensitivity and high specificity in prostate tumors.YiDiXie ™ -D has relatively high sensitivity and very high specificity in prostate tumors. YiDiXie ™-SS significantly reduces the rate of PSA or enhanced MRI false positives with essentially no increase in delayed treatment for prostate cancer.YiDiXie™-HS significantly reduces the rate of PSA or enhanced MRI false negatives.YiDiXie™-D significantly reduces the rate of PSA or enhanced MRI false positives or significantly reduces the rate of false negatives thereof while maintaining a high level of specificity. YiDiXie™ tests can play an important role in prostate cancer, and are expected to solve the problem of “high false-positive rate” and “high false-negative rate” of PSA or enhanced MRI. Clinical trial number ChiCTR2200066840.
Abstract Prostate cancer is the fifth leading cause of male cancer mortality and poses a serious threat to men's health worldwide. PSA testing is widely used in prostate cancer screening, but its high false-positive rate leads to unnecessarily high subsequent testing costs, mental anguish and potential physical harm to patients. Therefore, there is an urgent need to develop a convenient, cost-effective and non-invasive diagnostic method to assist in reducing the false-positive rate of PSA screening. The aim of this study was to evaluate the diagnostic value of serum MicroRNA expression in patients with prostate cancer. We selected 10 miRNAs in the literature that were associated with prostate cancer. Afterwards, we measured the expression levels of these miRNAs in serum of 112 prostate cancer patients and healthy controls through a training phase and a validation phase. By plotting receiver operating characteristic curve, the miRNAs with the highest diagnosis value were chosen. Then, a set of miRNAs with the top diagnostic value was identified using stepwise logistic regression. The findings showed that 5 kinds of miRNAs (let-7b-5p, miR-15a-5p, miR-133a-3p, miR-15b-5p, miR-144-3p) were abnormally expressed in the serum of prostate cancer patients. The diagnostic panel constructed with these 3 miRNAs including let-7b-5p, miR-15a-5p miR-15b-5p and which have high specificity and sensitivity in detecting prostate cancer (area under the curve (AUC) = 0.899). Our study illustrates the potential of a three-microRNA panel in the diagnosis of prostate cancer, which can help in the early detection of prostate cancer and may even assist in reducing the false-positive rate of PSA screening.
Background Cancer is a serious threat to the whole of humanity. The Multi-Cancer Early Detection (MCED) test is expected to solve the problem of “Universal cancer screening”. The purpose of this study is to evaluate the MCED value of two MCED tests, YiDiXie™-HS and YiDiXie™-SS, in multiple cancer types. Patients and methods 11094 subjects were finally included in this study (the malignant tumor group, n = 4405; the normal control group, n = 6689). The malignant tumor group included all major solid and hematological malignant tumor types. The sensitivity and specificity of YiDiXie™-HS and YiDiXie™-SS were evaluated, respectively. Results The overall sensitivity of YiDiXie™-HS for different cancer types and stages was 90.1% (89.2% - 90.9%; 3971/4405), and its specificity was 89.7% (89.0% - 90.4%; 6002/6689). Its sensitivity increases with clinical stage: stage I, 85.6% (83.9% - 87.1%); stage II, 91.4% (89.6% - 93.0%); stage III, 93.9% (92.0% - 95.4%); and stage IV, 98.4% (96.9% - 99.2%). The overall sensitivity of YiDiXie™-SS for different cancer types and stages was 99.1% (98.8% - 99.3%; 4365/4405), and its specificity was 65.2% (64.0% - 66.3%; 4358/6689). Its sensitivity was basically comparable in each clinical stage: stage I, 98.6% (98.0% - 99.1%); stage II, 99.5% (98.9% - 99.8%); stage III, 99.5% (98.6% - 99.8%); stage IV, 99.8% (98.9% - 100.0%). Conclusion YiDiXie™-HS has a high sensitivity in all clinical stages of all cancer types. YiDiXie™-SS has an extremely high sensitivity in all clinical stages of all cancer types. YiDiXie™-HS and YiDiXie™-SS can replace existing cancer screening tests and are expected to solve the world problem of “Universal cancer screening”. Clinical trial number ChiCTR2200066840.
Background Gastric cancer poses a severe risk to public health and has a substantial financial impact. Tumor markers such as CEA, CA125, CA19-9, and others, as well as the fecal occult blood test (FOBT), are frequently utilized for gastric cancer screening and initial diagnosis. However, false-positive results of FOBT, CEA, CA125, and CA19-9 can lead to misdiagnosis and erroneous gastroscopy, while their false-negative results can lead to missed diagnosis and delayed treatment. Finding practical, affordable, and non-invasive diagnostic techniques is crucial to lowering the false-positive and false-negative rates of FOBT and other markers. The aim of this study was to evaluate the diagnostic value of YiDiXie ™-SS, YiDiXie™-HS and YiDiXie™-D in gastric cancer. Patients and methods This study included 602 subjects (Malignant group, n=222; Benign group, n=380 cases). The remaining serum samples of the subjects were collected and the sensitivity and specificity of the YiDiXie™-SS, YiDiXie™ -HS and YiDiXie™-D were evaluated using the YiDiXie™ all-cancer detection kit. Results The sensitivity of YiDiXie™-SS was 99.5% (95% CI: 97.5% - 100%) and its specificity was 64.5% (95% CI: 59.5% - 69.1%). This means that YiDiXie™-SS has an extremely high sensitivity and relatively high specificity in gastric tumors.YiDiXie™-HS has a sensitivity of 96.8% (95% CI: 93.6% - 98.5%) and a specificity of 89.5% (95% CI: 86.0% - 92.2%). This means that YiDiXie™ -HS has high sensitivity and high specificity in gastric tumors. The sensitivity of YiDiXie™-D was 83.3% (95% CI: 77.9% - 87.7%) and its specificity was 95.5% (95% CI: 93.0% - 97.2%). This means that YiDiXie™-D has relatively high sensitivity and very high specificity in gastric tumors. YiDiXie™-SS significantly reduced the false-positive rates of FOBT, CEA, CA125, and CA19-9 with essentially no increase in malignancy leakage.YiDiXie™-HS substantially reduced the false-negative rates of FOBT, CEA, CA125, and CA19-9. YiDiXie™-D significantly reduces the false positive rate of FOBT, CEA, CA125, CA19-9. YiDiXie™-D significantly reduces the false negative rate of FOBT, CEA, CA125, CA19-9 while maintaining a high level of specificity. Conclusion YiDiXie™-SS has very high sensitivity and relatively high specificity in gastric tumors.YiDiXie™-HS has high sensitivity and high specificity in gastric tumors.YiDiXie ™ -D has relatively high sensitivity and very high specificity in gastric tumors. YiDiXie ™ -SS significantly reduces the false-positive rates of FOBT, CEA, CA125, and CA19-9 with essentially no increase in delayed treatment of gastric cancer.YiDiXie™-HS significantly reduces the false-negative rates of FOBT, CEA, CA125, and CA19-9.YiDiXie™-D can significantly reduce the false-positive rate of FOBT, CEA, CA125 and CA19-9, or significantly reduce the false-negative rate of FOBT, CEA, CA125 and CA19-9 while maintaining a high degree of specificity. YiDiXie™ test has an important diagnostic value in gastric cancer, and is expected to solve the problems of “high false positive rate” and “high false negative rate” of FOBT, CEA, CA125 and CA19-9.
Background: Gallbladder cancer is a grave threat to human health and poses a severe economic burden. Enhanced CT is extensively used in the diagnosis of gallbladder tumors. However, false-positive results of enhanced CT can lead to misdiagnosis. As a result, patients have to bear unnecessary mental pain, expensive surgery and examination costs, surgical trauma, organ removal, loss of function, and even serious perioperative complications. False-negative enhanced CT results can lead to delayed treatment. Patients will thus have to bear the adverse consequences of negative prognosis, high treatment costs, poor quality of life, and short survival. There is an urgency to find convenient, cost-effective and noninvasive diagnostic methods to decrease the false-negative and false-positive rates of gallbladder-enhanced CT. The goal of this study was to assess the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in gallbladder cancer. Patients and methods: Fifty study subjects (malignant group, n=12; benign group, n=38 cases) were finally recruited in the study. Remaining serum samples from the subjects were collected and tested by applying YiDiXie™ all-cancer detection kit (YiDiXie™ all-cancer detection kit) to assess the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively. Results: YiDiXie™-SS had a sensitivity of 100% (95% CI: 75.8% - 100%) and a specificity of 65.8% (95% CI: 49.9% - 78.8%). YiDiXie™-HS had a sensitivity of 91.7% (95% CI: 64.6% - 99.6%) and a specificity of 84.2% (95% CI: 69.6% - 92.6%). YiDiXie™-D had a sensitivity of 41.7% (95% CI: 19.3% - 68.0%) and a specificity of 97.4% (95% CI: 86.5% - 99.9%). YiDiXie™-SS had a sensitivity of 100% (95% CI: 64.6% - 100%) and its specificity was 60.0% (95% CI: 31.3% - 83.2%) in patients with positive enhanced CT. This implies that the application of YiDiXie™-SS decreases the false-positive rate of enhanced CT of the gallbladder by 60.0% (95% CI: 31.3% - 83.2%) with essentially no increase in the leakage of gallbladder cancer. YiDiXie™-HS has a sensitivity of 80.0% (95% CI: 37.6% - 99.0%) in patients with a negative enhanced CT, and its specificity was 85.7% (95% CI: 68.5% - 94.3%). This implies that the application of YiDiXie™-HS reduces the false-negative rate of enhanced CT by 80.0% (95% CI: 37.6% - 99.0%). YiDiXie™-D has a sensitivity of 28.6% (95% CI: 5.1% - 64.1%) in patients with a positive enhanced CT and a specificity of 100% (95% CI: 72.2% - 100%). This implies that YiDiXie™-SS decreases the false positive rate of enhanced CT by 100% (95% CI: 72.2% - 100%). Conclusion: YiDiXie™-SS markedly decreased the rate of false-positive gallbladder-enhanced CT with basically no increase in deferred treatment of gallbladder cancer. YiDiXie™-HS significantly decreases the false-negative rate of gallbladder-enhanced CT. YiDiXie™-D significantly decreases the false-positive rate of gallbladder-enhanced CT. The YiDiXie™ test has an excellent diagnostic value in gallbladder cancer, and expected to address the problems of "high false-positive rate of enhanced CT" and "high false-negative rate of enhanced CT" in gallbladder tumors. Clinical trial number: ChiCTR2200066840. Key words: Gallbladder cancer, Enhanced CT, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS, YiDiXie™-D
Abstract OBJECTIVE Bladder carcinoma (BC) is a malignant tumor that is formed in the bladder of the genitourinary system. The diagnosis at an early stage is directly associated with the improved overall survival of BC patients because a later stage usually means a poorer prognosis. Current methods to diagnose BC have various limitations, thus urologists call for novel effective non-invasive diagnostic markers. Herein, we identified miRNAs which can be used for the diagnosis of BC. MATERIALS AND METHODS Patients with BC (n = 112) and healthy individuals (n = 112) were recruited and enrolled in this study. The quantitative reverse transcription-polymerase chain reaction (qRT-PCR) was carried out for the measurement of miRNAs expression in serum. A two-phase test was proceeded for the identification, selection, and confirmation of the miRNAs that could be used for BC diagnosis. A backward stepwise logistic regression (BSLR) was conducted to establish a model containing these miRNAs with superior diagnostic performance. In addition, bioinformatics and survival analysis was exerted by analyzing database in Mirwalk, Enrichr, and OncoLnc. RESULTS Five significantly aberrant miRNAs with good diagnostic value were validated, namely miR-129-2-3p, miR-29c-3p, miR-149-3p, miR-138-5p, and miR-194-5p. Then three of them (miR-129-2-3p, miR-29c-3p, and miR-149-3p) were used to establish a diagnostic panel, in which the area under the curve (AUC) was 0.927 (95% CI: 0.876 to 0.962), providing both high sensitivity (92.68%) and specificity (80.49%). CONCLUSION In this study, a panel of three miRNAs (miR-129-2-3p, miR-29c-3p, and miR-149-3p) was developed, which could be used for the diagnosis of BC sensitively and specifically.
Renal cell carcinoma (RCC) stands as the most prevalent form of urogenital cancer. However, there is currently no universally accepted method for predicting the prognosis of RCC. MiRNA holds great potential as a prognostic biomarker for RCC.
Background Uroepithelial carcinoma is a serious threat to human health and causes heavy economic burden. Enhanced CT is widely used in screening or preliminary diagnosis of uroepithelial tumors. However, false-positive results on enhanced CT can lead to misdiagnosis and incorrect endoscopy, while false-negative results on enhanced CT can lead to missed diagnosis and delayed treatment. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-negative and false-positive rates of enhanced CT in uroepithelial tumors. The aim of this study was to evaluate the diagnostic value of YiDiXie ™ -SS, YiDiXie ™ -HS and YiDiXie ™ -D in uroepithelial carcinoma. Patients and methods 319 subjects (malignant group, n=240; benign group, n=79) were finally included in this study. Remaining serum samples from the subjects were collected and tested by applying the YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity of YiDiXie™-SS and YiDiXie™-HS. Results The sensitivity of YiDiXie™ SS was 95.8% (95% CI: 92.5% - 97.7%) and its specificity was 64.6% (95% CI: 53.6% - 74.2%). This means that YiDiXie ™ -SS has an extremely high sensitivity and relatively high specificity in urothelial tumors.YiDiXie™-HS has a sensitivity of 85.8% (95% CI: 80.9% - 89.7%) and a specificity of 84.8% (95% CI: 75.3% - 91.1%). This means that YiDiXie™-HS has high sensitivity and specificity in urothelial tumors.YiDiXie™-D has a sensitivity of 73.3% (95% CI: 67.4% - 78.5%) and a specificity of 92.4% (95% CI: 84.4% - 96.5%). This means that YiDiXie ™ -D has relatively high sensitivity and very high specificity in urothelial tumors. The sensitivity of YiDiXie™-SS in enhanced CT-positive patients was 96.3% (95% CI: 96.3% - 98.3%)and its specificity was 64.3% (95% CI: 38.8% - 83.7%). This means that the application of YiDiXie™-SS reduces the false-positive rate of urological enhanced CT by 64.3% (95% CI: 38.8% - 83.7%) with essentially no increase in malignancy leakage. The sensitivity of YiDiXie™-HS in enhanced CT-negative patients was 85.5% (95% CI: 75.9% - 91.7%)and its specificity was 84.6% (95% CI: 73.9% - 91.4%). This means that the application of YiDiXie™-HS reduces the false-negative rate of urological enhanced CT by 85.5% (95% CI: 75.9% - 91.7%).YiDiXie™-D had a sensitivity of 75.6% (95% CI: 68.5% - 81.5%) and a specificity of 92.9% (95% CI: 68.5% - 99.6%) in patients with enhanced CT positivity. This means that YiDiXie ™ -D reduced the rate of false positives in enhanced CT by 92.9% (95% CI: 87.8% - 96.0%). YiDiXie ™ -D has a sensitivity of 68.4% (95% CI: 57.3% - 77.8%) and a specificity of 92.3% (95% CI: 83.2% - 96.7%) in patients with enhanced CT negativity. This means that YiDiXie™-D reduces the false-negative rate of enhanced CT by 68.4% (95% CI: 57.3% - 77.8%) while maintaining high specificity. Conclusion YiDiXie™-SS has extremely high sensitivity and relatively high specificity in urological tumors. YiDiXie™-HS has high sensitivity and high specificity in urological tumors. YiDiXie™-D has relatively high sensitivity and extremely high specificity in urological tumors. YiDiXie ™ -SS dramatically reduces urological enhanced CT false-positive rates with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS substantially reduces urological enhanced CT false-negative rates.YiDiXie ™ -D substantially reduces urological enhanced CT false-positive rates, or significantly reduces urological enhanced CT false-negative rates while maintaining high specificity. YiDiXie™ tests has important diagnostic value in uroepithelial cancer, and is expected to solve the problems of “high false positive rate” and “high false negative rate” of urological enhanced CT. Clinical trial number ChiCTR2200066840.
Background Ovarian cancer is a serious risk to human health and causes a heavy economic burden. Ultrasound is widely used in the diagnosis of ovarian tumors. However, false-positive ultrasound results can lead to false diagnosis, and patients will have to bear unnecessary mental pain, expensive surgery and examination costs, surgical trauma, organ removal, loss of function, and even serious complications in the perioperative period, and other adverse consequences. False-negative ultrasound results lead to delayed treatment, and patients will have to bear the consequences of poor prognosis, high treatment costs, poor quality of life, and poor survival. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-negative and false-positive rates of ovarian ultrasound. The purpose of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in Ovarian cancer. Patients and methods The study finally included 79 study subjects (malignant group, n=12; benign group, n=67). Remaining serum samples from the subjects were collected and tested by applying YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively. Results YiDiXie™-SS had a sensitivity of 100% (95% CI: 75.8% - 100%) and a specificity of 61.2% (95% CI: 49.2% - 72.0%). YiDiXie™ -HS had a sensitivity of 91.7% (95% CI: 64.6% - 99.6%) and a specificity of 86.6% (95% CI: 76.4% - 92.8%). The sensitivity of YiDiXie ™ -D was 33.3% (95% CI: 13.8% - 60.0%) and its specificity was 97.0% (95% CI: 89.8% - 99.5%). The sensitivity of YiDiXie™-SS in ultrasound-positive patients was 100% (95% CI: 67.6% - 100%) and its specificity was 61.9% (95% CI: 40.9% - 79.2%). This represents a 61.9% (95% CI: 40.9% - 79.2%) reduction in the rate of false-positive ovarian ultrasound with the application of YiDiXie™-SS with essentially no increase in malignant tumor under-diagnosis. The sensitivity of YiDiXie™-HS in ultrasound-negative patients was 75.0% (95% CI: 30.1% - 98.7%) and its specificity was 84.8% (95% CI: 71.8% - 92.4%). This means that the application of YiDiXie™-HS reduces the false negative rate of ultrasound by 75.0% (95% CI: 30.1% - 98.7%). YiDiXie™ -D had a sensitivity of 25.0% (95% CI: 4.4% - 59.1%) in ultrasound-positive patients and its specificity was 95.2% (95% CI: 77.3% - 99.8%). This represents a 95.2% (95% CI: 77.3% - 99.8%) reduction in the rate of ultrasound false positives with YiDiXie™-SS. Conclusion YiDiXie™-SS markedly reduced the false-positive rate of ovarian ultrasound with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS substantially reduced the false-negative rate of ovarian ultrasound. YiDiXie™ -D substantially reduced the false-positive rate of ovarian ultrasound. The YiDiXie™ test has an excellent diagnostic value in ovarian cancer, and promises to solve the problems of “high false-positive rate of ultrasound” and “high false-negative rate of ultrasound” in ovarian tumors. Clinical trial number ChiCTR2200066840.
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