Latest Research News on Tumor Marker: Feb 2021

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Latest Research News on Tumor Marker: Feb 2021

February 2, 2021 Cancer and Tumor 0

Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)

Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often, initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many tumor marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute–European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply. [1]

Tumor Marker Utility Grading System: a Framework to Evaluate Clinical Utility of Tumor Markers

Introduction of tumor markers into routine clinical practice has been poorly controlled, with few criteria or guidelines as to how such markers should be used. We propose a Tumor Marker Utility Grading System (TMUGS) to evaluate the clinical utility of tumor markers and to establish and investigational agenda for evaluation of new tumor markers. A Tumor Marker Utility Grading Worksheet has been designed. The initial portion of this worksheet is used to clarify the precise characteristics of the marker in question. These characteristics include the marker designation, the molecule and/or substance and the relevant alteration from normalcy, the assay format and reagents, the specimen type, and the neoplastic disease for which the marker is being evaluated. To determine the clinical utility of each marker, one of several potential uses must be designated, including risk assessment, screening, differential diagnosis, prognosis, and monitoring clinical course. For each of these uses, associations between marker assay results and expected biologic process and end points must be determined. However, knowledge of tumor marker data should contribute to a decision in practice that results in a more favorable clinical outcome for the patient, including increased overall survival, increased disease-free survival, improvement in quality of life, or reduction in cost of care. Semiquantitative utility scales have been developed for each end point. The only markers recommended for use in routine clinical practice are those that are assigned utility scores of “++” or “+++” on a 6-point scale (ranging from 0 to +++) in the categories relative to more favorable clinical outcomes. Each utility score assignment should be supported by documentation of the level of evidence used to evaluate the marker. TMUGS will establish a standardized analytic technique to evaluate clinical utility of known and future tumor markers. It should result in improved patient outcomes and more cost-efficient investigation and application of tumor markers. [2]

Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration

Background

The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published tumor marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report.

Methods

REMARK recommends including a transparent and full description of research goals and hypotheses, subject selection, specimen and assay considerations, marker measurement methods, statistical design and analysis, and study results. Each checklist item is explained and accompanied by published examples of good reporting, and relevant empirical evidence of the quality of reporting. We give prominence to discussion of the ‘REMARK profile’, a suggested tabular format for summarizing key study details.

Summary

The paper provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing tumor marker studies and prognostic studies in medicine in general.

To encourage dissemination of the Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration, this article has also been published in PLoS Medicine. [3]

Role of Tumor Markers in Oral Cancer: An Overview

The oral mucosa represents the first part of the digestive tract and is exposed to various exogenous toxins. Exposure for longer duration can lead to changes that lead to potentially malignant diseases or cancers / Tumors. Eventually these can be diagnosed by routine histopathology, but few of them are difficult to diagnose by this method alone. There arises the role of tumor markers in distinguishing different pathologies is well established. A marker can be described as some inconspicuous object used to distinguish or mark certain things. Mostly tumor markers are proteins and these markers may be detected within exfoliated or distributed cells, or as circulating agents within the peripheral blood or plasma. In the recent years, there is a renewed interest about tumor markers, providing window of opportunity for management of cancer patients by enhancing the efficiency in detection and treatment plan. Recent technological advancement has enabled the examination of many potential markers. This paper focuses on the tumor markers in the head and neck neoplasm. [4]

Ascitic Fluid Fibronectin: A Marker to Differentiate Between Malignant and Non-malignant Ascites

Background and Aims: So far, the differentiation between malignant and non-malignant ascites by laboratory parameters has not been fully achieved yet. Fibronectin is a glycoprotein which plays an important role in cell adhesion, growth, migration, and differentiation. The aim of the study was to assess the accuracy of fibronectin for the diagnosis of malignant ascites and to compare it with conventional use of cytology.

Study Design: A cross sectional study to determine the correlation between ascitic fluid fibronectin and malignant and non-malignant ascites.

Place and Duration of Study: This study was carried out at the clinics of gastroenterology, surgery, and obstetrics/gynecology at the Lagos University Teaching Hospital (LUTH), between August 2011 and July 2013.

Methods: Ascitic fluid and serum samples from 75 patients were taken. 37 of them (7 males and 30 females) had malignancy-related ascites (Group 1), while the other 38 (18 males and 20 females) had non-malignant ascites (Group 2) respectively. These were analysed for fibronectin, lactate dehydrogenase (LDH), total protein, and albumin. Cytology was also done for all ascitic fluid samples.

Results: Mean values of ascitic fluid fibronectin and LDH were higher in malignancy-related ascites (97.5 µg/ml, and 900.60 IU/L) respectively than in non-malignant ascites (47.7 µg/ml, and 199.31 IU/L) respectively (P less than 0.001). Ascitic fluid fibronectin with a cut-off value of 73 µg/ml gave the best diagnostic accuracy with a sensitivity and specificity of 94.7% and 94.6% respectively, while ascitic fluid LDH with a cut-off value of 310 IU/L gave diagnostic accuracy with a sensitivity and specificity of 97.3% and 84.2% respectively. The mean total protein level in the malignant group was 38.72±18.00 g/L and 30.21±15.00 g/L for the non-malignant group. The mean albumin levels were 28.08±10.32 g/L and 31.23±10.01 g/L for the malignant and non-malignant groups respectively. For both total protein and albumin, the P value was statistically insignificant. In this study, cytology yielded a sensitivity of 56.8% and a specificity of 100%.

Conclusion: The results of this study suggest that fibronectin concentration in ascitic fluid may be useful in differentiating malignant from non-malignant ascites and could supplement cytology in the differential diagnosis of ascites. Further studies are needed to confirm these results. [5]

Reference

[1] McShane, L.M., Altman, D.G., Sauerbrei, W., Taube, S.E., Gion, M. and Clark, G.M., 2005. Reporting recommendations for tumor marker prognostic studies (REMARK). Journal of the National Cancer Institute, 97(16), pp.1180-1184.

[2] Hayes, D.F., Bast, R.C., Desch, C.E., Fritsche Jr, H., Kemeny, N.E., Jessup, J.M., Locker, G.Y., Macdonald, J.S., Mennel, R.G., Norton, L. and Ravdin, P., 1996. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. JNCI: Journal of the National Cancer Institute, 88(20), pp.1456-1466.

[3] Altman, D.G., McShane, L.M., Sauerbrei, W. and Taube, S.E., 2012. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC medicine, 10(1), pp.1-39.

[4] Lavanya, R., Mamatha, B., Waghray, S., Chaitanya, N., Reddy, M. P. and Bau, D. B. (2016) “Role of Tumor Markers in Oral Cancer: An Overview”, Journal of Advances in Medicine and Medical Research, 15(7), pp. 1-9. doi: 10.9734/BJMMR/2016/24998.

[5] Ekpe, E. E. L., Azinge, E. C. and Bolarin, D. M. (2015) “Ascitic Fluid Fibronectin: A Marker to Differentiate Between Malignant and Non-malignant Ascites”, Journal of Advances in Medicine and Medical Research, 8(1), pp. 30-40. doi: 10.9734/BJMMR/2015/12615.

 

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