Validation of plasma miR-371a-3p expression in patients with metastatic and early stage germ cell tumor.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 526-526 ◽  
Author(s):  
Lucia Nappi ◽  
Marisa Thi ◽  
Amy Lum ◽  
David Huntsman ◽  
Bernhard J. Eigl ◽  
...  
Keyword(s):  
Germ Cell ◽  
Validation Cohort ◽  
Early Stage ◽  
Clinical Stage ◽  
Diagnostic Tools ◽  
Rt Pcr ◽  
Predictive Values ◽  
Sensitivity Specificity ◽  
Cell Malignancy

526 Background: Identification of relapsing/residual viable germ cell malignancy (GCM) is often challenging in patients with CSI on surveillance or with residual post-chemotherapy disease. The presence of a biomarker for GCM would overcome the uncertainty of the current methods and improve the quality of care of those patients. Methods: A 2-cohorts pilot study involving patients with clearcut evidence of GCM (clinical stage IS, metastatic and GCM prior orchiectomy) for the development cohort and patients with CSI with or without signs of tumor relapse and patients with metastatic GCM post-chemotherapy for the validation cohort. Blood samples collected in Streck tubes were obtained prior to chemotherapy for the development cohort and post-orchiectomy, at the time of suspicious relapse or post-chemotherapy in the validation cohort. Plasma miR-371a-3p (miR371) was analyzed by RT-PCR. Positive predictive value (PPV), sensitivity, specificity, negative predictive values (NPV) and AUC of the ROC for miR371 and standard diagnostic tools (CT scan, AFP, BHCG and LDH) were calculated correlating qualitative miR371 expression to the presence of viable GCM. Results: 132 patients were enrolled into the development (33 pts) and validation (99 pts) cohorts. Within the development cohort 31/33 pts were miR371 positive, 2/33 pts were negative. 31 true positives were found among the 31 miR371 positive patients for a PPV of 100% (31/31). Two true negatives were found among the 2 patients who had no miR371 expression identified (teratoma, lymphoma). The validation cohort was chosen to evaluate the methodology among patients with predicted lower volumes or no clinically apparent disease. 13/99 patients within the validation cohort were miR371 positive and all 13 had subsequent confirmation of viable GCM. For the overall study of 132 pts, PPV was 100% (46/46), NPV 98%, sensitivity 96% and specificity 100%, the AUC of the ROC was 0.96. Conclusions: Detectable circulating miR-371a-3p levels predict viable GCM and may represent a strategy for biological rather than radiographic assessment for surveillance of early stage and for post-treatment patients. Larger studies to validate these and like results have been planned.

scholarly journals Comparison of saliva with healthcare workers- and patient-collected swabs in the diagnosis of COVID-19 in a large cohort

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mitnala Sasikala ◽  
Yelamanchili Sadhana ◽  
Ketavarapu Vijayasarathy ◽  
Anand Gupta ◽  
Sarala Kumari Daram ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Early Stage ◽  
Cost Effective ◽  
Hospitalized Patients ◽  
Detection Sensitivity ◽  
Nasopharyngeal Swab ◽  
Predictive Values ◽  
Qrt Pcr ◽  
Asymptomatic Patients ◽  
Sensitivity Specificity

Abstract Background A considerable amount of evidence demonstrates the potential of saliva in the diagnosis of COVID-19. Our aim was to determine the sensitivity of saliva versus swabs collected by healthcare workers (HCWs) and patients themselves to assess whether saliva detection can be offered as a cost-effective, risk-free method of SARS-CoV-2 detection. Methods This study was conducted in a hospital involving outpatients and hospitalized patients. A total of 3018 outpatients were tested. Of these, 200 qRT-PCR-confirmed SARS-CoV-2-positive patients were recruited for further study. In addition, 101 SARS-CoV-2-positive hospitalized patients with symptoms were also enrolled in the study. From outpatients, HCWs collected nasopharyngeal swabs (NPS), saliva were obtained. From inpatients, HCWs collected swabs, patient-collected swabs, and saliva were obtained. qRT-PCR was performed to detect SARS-CoV-2 by TAQPATH assay to determine the sensitivity of saliva detection. Sensitivity, specificity and positive/negative predictive values (PPV, NPV) of detecting SARS-CoV-2 were calculated using MedCalc. Results Of 3018 outpatients (asymptomatic: 2683, symptomatic: 335) tested by qRT-PCR, 200 were positive (males: 140, females: 60; aged 37.9 ± 12.8 years; (81 asymptomatic, 119 symptomatic). Of these, saliva was positive in 128 (64%); 39 of 81 asymptomatic (47%),89 of 119 symptomatic patients (74.8%). Sensitivity of detection was 60.9% (55.4–66.3%, CI 95%), with a negative predictive value of 36%(32.9–39.2%, CI 95%).Among 101 hospitalized patients (males:65, females: 36; aged 53.48 ± 15.6 years), with HCW collected NPS as comparator, sensitivity of saliva was 56.1% (47.5–64.5, CI 95%), specificity 63.5%(50.4–75.3, CI95%) with PPV of 77.2% and NPV of 39.6% and that of self-swab was 52.3%(44–60.5%, CI95%), specificity 56.6% (42.3–70.2%, CI95%) with PPV 77.2% and NPV29.7%. Comparison of positivity with the onset of symptoms revealed highest detection in saliva on day 3 after onset of symptoms. Additionally, only saliva was positive in 13 (12.8%) hospitalized patients. Conclusion Saliva which is easier to collect than nasopharyngeal swab is a viable alternate to detect SARS-COV-2 in symptomatic patients in the early stage of onset of symptoms. Although saliva is currently not recommended for screening asymptomatic patients, optimization of collection and uniform timing of sampling might improve the sensitivity enabling its use as a screening tool at community level.

Reliability of administrative data for evaluating the quality of systemic treatment for cancer.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 208-208 ◽  
Author(s):  
Melanie Lynn Powis ◽  
Nathan Taback ◽  
Christina Diong ◽  
Katherine Enright ◽  
Christopher M. Booth ◽  
...  
Keyword(s):  
Administrative Data ◽  
Gold Standard ◽  
Validation Cohort ◽  
Systemic Treatment ◽  
Early Stage ◽  
Quality Measures ◽  
Administrative Databases ◽  
Study Cohort ◽  
Reliability Characteristics

208 Background: There is ongoing interest in leveraging administrative data to examine quality but methodological concerns persist. We evaluated the reliability of a previously established panel of administrative data derived quality measures for systemic cancer treatment. Methods: The study cohort consisted of women diagnosed with early stage (stage I-III) breast cancer (ESBC) in Ontario, Canada, in 2010. Performance on 11 quality indicators evaluated using deterministically linked healthcare administrative databases has been reported previously. The sensitivity and specificity of these 11 indicators were examined using the chart as the gold standard. Results: The administrative cohort consisted of 6,795 women with ESBC from which a validation cohort of 705 patients was randomly selected from among patients who underwent cancer surgery at one of five hospitals chosen to balance feasibility and institutional characteristics.Sensitivity and specificity varied by indicator (Table). Reliability of some indicators may have been affected by suboptimal chart documentation in instances where care spanned multiple settings or the medical record was fragmented, or where the number of eligible patients for that indicator was low. Conclusions: Administrative data can be used to evaluate quality of systemic cancer therapy but understanding the reliability characteristics of individual indicators is essential to inform their appropriate use and interpretation. [Table: see text]

scholarly journals Low sensitivity of ParaHIT-f rapid malaria test among patients with fever in rural health centers, Northern Tanzania

2011 ◽  
Vol 5 (03) ◽  
pp. 204-208 ◽  
Author(s):  
Eliningaya John Kweka ◽  
Asanterabi Lowassa ◽  
Shandala Msangi ◽  
Epiphania E Kimaro ◽  
Ester E Lyatuu ◽  
...  
Keyword(s):  
Rapid Test ◽  
Health Centers ◽  
Diagnostic Tools ◽  
Test Results ◽  
Predictive Values ◽  
Rural Tanzania ◽  
Northern Tanzania ◽  
Low Sensitivity ◽  
Sensitivity Specificity ◽  
Malaria Test

Introduction: Several rapid diagnostic tools for malaria are currently available in local markets. However, diagnostic accuracy varies widely. The present study was conducted to evaluate a cheaply and easily available rapid diagnostic malaria test (ParaHIT-f) in rural Tanzania. Methodology: Participants presenting with fever at health centers in the Kilimanjaro and Manyara regions were eligible. Parasitological thin and thick smears were examined from finger-prick blood samples and compared to ParaHIT-f test results. Sensitivity, specificity and predictive values were calculated using microscopic parasitological examination as the gold standard. Results: In total, 236/743 (31.8%) individuals had a positive malaria microscopy, and 25/715 (3.4%) were positive in the rapid diagnostic test. The sensitivity of ParaHIT-f was 10.7% (95% CI, 6.7-14.7) and specificity was 100% (95% CI, 97.4-102), with positive and negative predictive values (PPV and NPV) of 100% (95% CI, 99.1-100.2) and 70.9% (95% CI, 66.9-74.9) respectively. Sensitivity of ParaHIT-f increased with increasing P. falciparum density (P > 0.003) from 5.8% (95% CI, 0-12.9) at < 100 parasites/μl to 20.5% (95% CI, 13.5-27) at ≥ 100 parasites/μl. Conclusions: Sensitivity of the ParaHIT-f rapid test was very low in this setting, therefore concomitant use of rapid diagnostic tests and microscopy is recommended. In the case of positive test results, confirmation by parasitological techniques is not necessary. Further monitoring of ParaHIT-f in various epidemiological settings in Tanzania is warranted. 

Diagnostic Potential of Host Response Mediators

1993 ◽  
Vol 7 (2) ◽  
pp. 175-181 ◽  
Author(s):  
S. Offenbacher ◽  
J.G. Collins ◽  
P.A. Heasman
Keyword(s):  
Disease Activity ◽  
Host Response ◽  
Gingival Crevicular Fluid ◽  
Diagnostic Tools ◽  
Predictive Values ◽  
Diagnostic Measures ◽  
Diagnostic Potential ◽  
Crevicular Fluid ◽  
Sensitivity Specificity ◽  
Considerable Body

This review summarizes the data which relate the validation and application of host response markers as diagnostic tests forperiodontal diseases. Practical considerations regarding the general application and evaluation of a diagnostic test for periodontal disease are presented. Experiments which have documented the performance of host response markers as diagnostic measures of disease activity in terms of sensitivity, specificity, and predictive values are summarized. Particular emphasis is placed on the diagnostic potential of gingival crevicular fluid (GCF) components. The considerable body of evidence supporting the potential application of GCF-PGE2 levels for predicting episodes of disease progression and reflecting disease activity is summarized and placed into perspective for the development of future diagnostic tools.

scholarly journals Dog Savior: Immediate Scent-Detection of SARS-COV-2 by Trained Dogs

2020 ◽  
Author(s):  
Omar Vesga ◽  
Andres F. Valencia ◽  
Alejandro Mira ◽  
Felipe Ossa ◽  
Esteban Ocampo ◽  
...  
Keyword(s):  
Infected Individual ◽  
High Sensitivity ◽  
The Body ◽  
High Rate ◽  
Diagnostic Tools ◽  
Predictive Values ◽  
Infected People ◽  
Molecular Tests ◽  
Production And Distribution ◽  
Sensitivity Specificity

AbstractMolecular tests for viral diagnostics are essential to confront the COVID-19 pandemic, but their production and distribution cannot satisfy the current high demand. Early identification of infected people and their contacts is the key to being able to isolate them and prevent the dissemination of the pathogen; unfortunately, most countries are unable to do this due to the lack of diagnostic tools. Dogs can identify, with a high rate of precision, unique odors of volatile organic compounds generated during an infection; as a result, dogs can diagnose infectious agents by smelling specimens and, sometimes, the body of an infected individual. We trained six dogs of three different breeds to detect SARS-CoV-2 in respiratory secretions of infected patients and evaluated their performance experimentally, comparing it against the gold standard (rRT-PCR). Here we show that viral detection takes one second per specimen. After scent-interrogating 9,200 samples, our six dogs achieved independently and as a group very high sensitivity, specificity, predictive values, accuracy, and likelihood ratio, with very narrow confidence intervals. The highest metric was the negative predictive value, indicating that with a disease prevalence of 7.6%, 99.9% of the specimens indicated as negative by the dogs did not carry the virus. These findings demonstrate that dogs could be useful to track viral infection in humans, allowing COVID-19 free people to return to work safely.

Diagnostic strategy based on preoperative serum CEA levels in clinical stage IA NSCLC

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17011-17011 ◽  
Author(s):  
N. Sawabata ◽  
M. Okada ◽  
M. Higashiyama ◽  
K. Nakagawa ◽  
M. Miyake ◽  
...  
Keyword(s):  
Clinical Stage ◽  
Stage Iii ◽  
Diagnostic Strategy ◽  
Advanced Stage ◽  
Predictive Values ◽  
Cox Regression Analysis ◽  
Clinical Stage Ia ◽  
Stage Ia ◽  
Serum Cea ◽  
Sensitivity Specificity

17011 Background: Following surgery, clinical stage IA NSCLC diagnosed using non-interventional examinations is occasionally pathological stage III or IV. The level of carcinoembryonic antigen (CEA) in serum has been reported to be a predictor of up-staging to advanced stages, however, there are few multi-center studies of serum CEA that utilized a short accrual period. Methods: A multi-center retrospective study was performed to assess serum CEA level as a predictor of advanced stage in 862 consecutive patients with clinical stage IA NSCLC from 2002 to 2004. The subjects were 493 males with a mean age of 65.2 years old, 460 of whom were smokers, who had a total of 689 adenocarcinomas with a mean tumor size of 19.5 cm. They were divided into 4 groups by smoking status and adenocarcinoma histology, after which AUC was calculated using an ROC curve, which provided an estimate of the probability efficiency of pathological diagnosis of stage III or stage IV. When AUC was greater than 0.7, sensitivity, specificity, and positive predictive values were calculated, and multivariate Cox regression analysis was performed to confirm independence. Results: There were 72 cases (8.1%) in an advanced stage. AUC was greater than 0.7 in the group of non-smokers with an adenocarcinoma (n = 413), in which the sensitivity, specificity, and positive predictive values were 0.14, 0.97, and 0.64, respectively, with a CEA cut-off level of 20 ng/ml. Thus, serum CEA level was shown to be an independent predictive factor. Conclusions: In smokers with an adenocarcinoma, a high level of CEA in serum was frequently found in those with pathologically advanced disease, thus intervention should be mandated in such cases. [Table: see text] No significant financial relationships to disclose.

Reliability of administrative data for evaluating quality of systemic cancer treatment.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18269-e18269
Author(s):  
Monika K. Krzyzanowska ◽  
Melanie Lynn Powis ◽  
Nathan Taback ◽  
Christina Diong ◽  
Katherine Enright ◽  
...  
Keyword(s):  
Administrative Data ◽  
Gold Standard ◽  
Validation Cohort ◽  
Systemic Treatment ◽  
Early Stage ◽  
Quality Measures ◽  
Administrative Databases ◽  
Appropriate Use ◽  
Reliability Characteristics

e18269 Background: There is ongoing interest in leveraging administrative data to examine quality but methodological concerns persist. We evaluated the reliability of a previously established panel of administrative data derived quality measures for systemic treatment. Methods: The cohort consisted of women diagnosed with early stage (stage I-III) breast cancer (ESBC) in Ontario, Canada, in 2010. Performance on 11 quality indicators evaluated using deterministically linked healthcare administrative databases has been reported previously. Sensitivity and specificity were examined using the chart as the gold standard. Results: The administrative cohort consisted of 6,795 women with ESBC from which a validation cohort of 705 patients was randomly selected from among patients who underwent cancer surgery at one of five hospitals chosen to balance feasibility and institutional characteristics.Sensitivity and specificity varied by indicator (Table 1). Reliability of some indicators may have been affected by suboptimal chart documentation in instances where care spanned multiple settings or the medical record was fragmented, or where the number of eligible patients for that indicator was low. Conclusions: Administrative data can be used to evaluate quality of systemic cancer therapy but understanding the reliability characteristics of individual indicators is essential to inform their appropriate use and interpretation. [Table: see text]

scholarly journals Clinical and Radiologic Signs of Relapsed Ovarian Germ Cell Tumor: Tissue Is the Issue

2013 ◽  
Vol 2013 ◽  
pp. 1-4
Author(s):  
M. Y. V. Homs ◽  
H. W. R. Schreuder ◽  
G. N. Jonges ◽  
P. O. Witteveen
Keyword(s):  
Germ Cell ◽  
Germ Cell Tumor ◽  
Early Stage ◽  
Mature Teratoma ◽  
Treatment Strategies ◽  
Current Treatment ◽  
Cell Tumor ◽  
Diagnostic Tools ◽  
Tumor Biopsy ◽  
Platinum Based Chemotherapy

Malignant ovarian germ cell tumor is a rare disease, but with current treatment strategies including surgery and platinum based chemotherapy survival is excellent. After treatment, intensive followup is indicated to encounter tumor relapse at an early stage. This case describes a 22-year-old female with a history of common variable immune deficiency (CVID) who underwent a resection of a large ovarian germ cell tumor followed by 4 cycles of cisplatin and etoposide resulting in clinical complete remission. During followup, she developed a mass at the umbilicus and ascites. Initially, the cytology of the ascites was interpreted as tumor positive, suspicious of relapse of the disease, but tumor markers remained negative. However, during laparoscopy it turned out to be a mature teratoma, which can develop after chemotherapy, the so called growing teratoma syndrome. In retrospect, the ascites was false positive. This case shows that current diagnostic tools are not sufficient to distinguish between vital tumor and mature teratoma and can be misleading. Tumor biopsy and/or laparoscopic inspection are therefore indicated.

scholarly journals Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages

2021 ◽  
pp. 1-12
Author(s):  
Sabine Kliesch ◽  
Stefanie Schmidt ◽  
Doris Wilborn ◽  
Clemens Aigner ◽  
Walter Albrecht ◽  
...  
Keyword(s):  
Germ Cell ◽  
Clinical Stage ◽  
Cell Cancer ◽  
Interdisciplinary Approach ◽  
Treatment Recommendations ◽  
Classification Systems ◽  
Adult Patients ◽  
Germ Cell Tumours ◽  
Clinical Recommendations

<b><i>Introduction:</i></b> This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic’s background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages. <b><i>Methods:</i></b> An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements. <b><i>Results:</i></b> We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma. <b><i>Conclusion:</i></b> Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group classification after careful diagnostic evaluation. An interdisciplinary approach as well as the referral of selected patients to centres with proven experience can help achieve favourable clinical outcomes.

scholarly journals Comparison of diagnostic accuracy of Midkine and AFP for detecting hepatocellular carcinoma: a systematic review and meta-analysis

2020 ◽  
Vol 40 (3) ◽  
Author(s):  
Qingqing Lu ◽  
Jie Li ◽  
Hui Cao ◽  
Chenlu Lv ◽  
Xiaolin Wang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Diagnostic Accuracy ◽  
Hepatitis Virus ◽  
Early Stage ◽  
Meta Analysis ◽  
Area Under The Curve ◽  
Cochrane Library ◽  
Sensitivity Specificity ◽  
The Cochrane Library

Abstract Objective: Midkine (MDK) has been proposed as one of the most promising markers for hepatocellular carcinoma (HCC). This meta-analysis was conducted to compare the diagnostic accuracy of MDK and α-fetoprotein (AFP) for HCC. Methods: We systematically searched PubMed/MEDLINE, Ovid/EMBASE, and the Cochrane Library for all relevant studies up to 18 May 2019. The Revised Quality Assessment for Studies of Diagnostic Accuracy tool (QUADAS-2) was used to assess the methodological quality of the included studies. The sensitivity, specificity, and the area under the curve (AUC) of MDK and AFP for detecting HCC were pooled using random-effects model. Results: Seventeen studies from five articles with a total of 1122 HCC patients and 2483 controls were included. The summary estimates using MDK and AFP for detecting HCC were as follows: sensitivity, 85 vs 52%, specificity, 82 vs 94%, and AUC, 0.90 vs 0.83. The summary estimates using MDK and AFP for detecting hepatitis virus-related HCC as follows: sensitivity, 93 vs 74%, specificity, 85 vs 97%, and AUC, 0.95 vs 0.97. The summary estimates using MDK and AFP for detecting early-stage HCC were as follows: sensitivity, 83.5 vs 44.4%, specificity, 81.7 vs 84.8%, and AUC, 0.87 vs 0.52. The summary estimates using MDK for detecting AFP-negative HCC as follows: sensitivity, 88.5%, specificity, 83.9%, and AUC, 0.91. Conclusion: MDK is more accurate than AFP in diagnosing HCC, especially for early-stage HCC and AFP-negative HCC. Both MDK and AFP had excellent diagnostic performance for hepatitis virus-related HCC.

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