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Highlighting the latest news in biomarkers in medicine

Simple protein test could distinguish HPV-associated oral cancer and lead to personalized treatment New research from The University of Man­ chester (Manchester, UK) and published in the journal Clinical Oncology has proposed that a protein test may identify biomarkers for survival in head and neck cancer patients more effectively than current methodologies. The occurrence of oral cancers is most commonly attributed to alcohol consumption and tobacco intake, although these cancers – often involving the tonsils and tongue – are more frequently being associated with the human papillomaviruses (HPV). The num­ ber of oral cancer cases with this origin is growing; these are more common in younger individuals who usually present with a more ­promising ­prognosis. Currently, the identi­ ­ fication of HPV DNA in a tumor sample is used to distinguish HPV-associated oral cancer, yet this method does not nec­

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essarily classify the tumor. A second approach utilizes a marker of HPV as an alternative; this is protein p16, which has been demonstrated as absent in tumors not linked to the HPV infection. The present study, completed by a Can­ cer Research UK (London, UK)-funded research team, investigated the differences in survival, treatment and clinical character­ istics between p16-negative and p16-positive oral cancers. These samples were obtained from over 200 oral cancer patients. Findings identified that tumor stage could be linked to survival in p16-negative tumors; however, this was not true for the p16-positive tumors. Furthermore, the research concluded that a strong association was present between p16-positive tumors and increased survival. “We know that in most cases, p16 is linked to differences in survival. We wanted to see how it compared to other measures such as the stage of disease – which tells us the size and spread of the cancer. Any­ thing that allows us to predict outcome could help doctors plan more personal­ ized treatments for individual patients,” Reports ­Catharine West (University of ­Manchester). The researchers believe that this simple protein test and biomarker could lead to personalized treat­ ment for oral cancers in future, allowing physicians to choose the most appropriate therapy for the patient. Professor West concludes, “Despite presenting with a more advanced stage of cancer, patients whose tumors tested positive for p16 had greater survival when com­ pared with p16-negative patients. Applying this test in the clinic could help guide treatment decisions and potentially

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News & Views   allow doctors to choose more appropriate and tai­ lored treatments. Many studies have now shown p16 status is strongly linked to survival. Now we have

shown the test works better than routine staging for some cancers, we would recommend this test be offered as standard.”

– Written by Elizabeth Webb Source: University of Manchester press release: www.manchester.ac.uk/aboutus/news/display/?id=11464; also featured on www.oncology-central.com

New biomarker for necrotizing enterocolitis may lead to reduced incidence of the condition in premature infants Investigators at Loyola University Health System (IL, USA) have demonstrated that a biomarker may iden­ tify premature infants who are at risk of necrotizing enterocolitis (NEC). This could allow physicians to implement preventative measures and possibly reduce the incidence of NEC. NEC is a bowel infection that can threaten the lives of premature infants, presenting a mortality rate of almost 30%. It is the most common, serious gastro­intestinal condition affecting 10% of infants with extremely low birth weights and arising when tissue of the intestinal wall dies and detaches. NEC cases are frequently mild to moderate and can be treated by antibiotics; however, if a hole occurs in the intestine, the leak of bacteria can cause a life-threat­ ening infection. Currently, the cause of the disorder is unknown; however, researchers propose the con­ dition could be due to feeding patterns, infection, abnormal immune response, decreased blood flow to the bowel or mechanical injury, or a combination of these factors. The present research, published in the Journal of Pediatric Surgery involved the study of infants born weighing less than 1500 g or born prior to 32 weeks

gestation. Research examined blood samples from 177 infants during the 72-h window after birth and each week subsequently for 4 weeks. Further specimens were collected at the onset of NEC and 24 following. This allowed for measurement of intestinal alkaline phosphatase (iAP) and reticulated platelets (RPs). The findings demonstrated that 8.5% of the infants suffered from NEC, of which 60% presented with high levels of iAP (>0 U/l) and 93% with low levels of RP (≤2.3%). It was therefore concluded that infants with the high iAP levels were more likely to develop NEC. Similarly, the infants presenting with decreased RP levels were also more likely to suffer from NEC; however, the RP correlation was demonstrated to be statistically significant. “This information will allow us to better care for these premature infants. Simple changes to blood transfusion practices, feeding patterns and treatment of these infants may significantly reduce the incidence of NEC,” Comments Jonathan Muraskas (Loyola Uni­ versity Health System). “Decreased reticulated plate­ lets serve as a sensitive indicator for NEC onset. Fur­ ther research also may find that infants with elevated iAP levels may be at risk for this serious illness.”

– Written by Elizabeth Webb Sources: Kampanatkosol R, Thomson T, Habeeb O et al. The relationship between reticulated platelets, intestinal alkaline phosphatase, and necrotizing enterocolitis. J. Pediatr. Surg. doi:10.1016/j.jpedsurg.2013.11.037 (2014) (Epub ahead of print); Loyola University Health System press release: http://loyolamedicine.org/newswire/news/loyola-researchers-identify-risk-factor-lifethreatening-disease-preemies

Use your head and your heart: a brain injury biomarker shows promise in assessing myocarditis Research published in the Journal of Cardiovascular Translational Research has highlighted the use of a brain injury biomarker, translocator protein 18 kDa

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(TSPO), in assessing the severity of myocarditis. It is proposed that this marker may lead to the design of a novel noninvasive test for inflammation of the heart.

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Myocarditis, heart inflammation, can lead to heart failure and mortality, yet currently there is no non­ invasive test to diagnose the condition. Confirma­ tion of diagnosis requires a biopsy, which can put the patient at risk and does not always pick up the condi­ tion, meaning many patients may be unaware that they are suffering from myocarditis at all. Investigators from Columbia University’s Mailman School of Public Health (NY, USA), Johns Hopkins (MD, USA) and the Mayo Clinic (MN, USA) aimed to tackle these current pitfalls by evaluating whether a marker for brain inflammation could be translated to the heart. Once physicians have determined the dam­ age to the brain after injury, a PET scan is used to iden­ tify whether levels of the marker in question, TSPO, which is present throughout the body in immune cells, are elevated. The present research involved the assess­ ment of TSPO in biopsied tissue from both humans and mice with myocarditis by SPECT imaging. SPECT findings indicated TSPO levels were higher in male mice when compared with controls, and fur­ ther genetic testing also highlighted elevated TSPO in men with myocarditis. Levels of CD11b (a marker for TSPO containing immune cells) were also assessed and revealed to be increased in these individuals. The investigators state that the gender differences are due to sex hormones with TSPO playing an important part in their metabolism. “Testosterone amplifies inflam­ mation in a bad way that leads to permanent dam­ age in the heart and heart failure,” comments DeLisa

News & Views

Fairweather (Johns Hopkins). “This is why men are at greater risk for myocarditis and all heart conditions related to inflammation.” Fairweather also states: “We should be able to detect the acute stage of inflamma­ tion in women and determine if they are at a risk to progress to heart failure.” Further strengthening TSPO’s role as a biomarker, the researchers propose that it may impact a patient’s prognosis. Fairweather reports, “TSPO is directly related to whether patients are going to develop severe myocarditis and heart failure. That means it’s ­important to look at for its prognostic value.” The future of this research will likely involve the completion of a small trial at Mayo Clinic. This would aim to determine if inflammation in myocar­ ditis patients could be detected by TSPO. Following this, larger studies with noninflamed patients would be necessary to identify a threshold for the TSPO level that would diagnose myocarditis and in the long term may lead to a noninvasive method for confirming a ­myocarditis diagnosis. Tomas Guilarte (Columbia’s Mailman School), who is a key figure in TSPO research, concludes “Our lat­ est study is a major milestone because it demonstrates that we can take what we learned about TSPO in the brain and draw lessons for the heart. Indeed, TSPO will likely have implications for other organ systems. At the same time, we should be able to take what we are learning about TSPO in the heart and apply it to our continuing TSPO research in the brain.”

– Written by Elizabeth Webb Source: Columbia University Mailman School of Public Health press release: www.mailman.columbia.edu/news/brain-biomarker-shows-promise-heart

Research reveals a blood test may lead to even earlier prediction of diabetes risk Researchers from Tel Aviv University (Tel Aviv, Israel) have proposed a simple blood test that could uncover an individual’s risk of developing Type 2 diabetes earlier than current tests. This may lead to earlier ­diagnosis and treatment for patients. “Our study supports the idea that the A1c test, used to diagnose Type 2 diabetes, can also be used at a much earlier stage to screen for the disease in the high risk population, like overweight patients,” comments Nataly Lerner (Tel Aviv University). In the USA over 25 million individuals are estimated to have diabetes, with almost 80 million likely to pres­ ent with ‘prediabetes’, meaning they are risking the development of Type 2 diabetes. Individuals suffering

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from this type of diabetes have elevated blood glucose levels due to an insulin resistance that affects the regu­ lation of fat and carbohydrates. Prediabetic individuals present with an elevated blood glucose level compared with normal healthy individuals, but a level lower than diabetics. Directly testing blood glucose can provide a short-term evaluation of glucose levels. Glycated hemo­ globin (A1c) provides an indication of blood glucose levels over time and is commonly used for the monitor­ ing of Type 2 diabetes. Increased A1c formation occurs with high levels of blood glucose, therefore making A1c a biomarker for blood glucose over 2–3 months. An A1c level of ≥6.5% represents a diabetic, and an A1c level between 5.7 and 6.4% may indicate prediabetes.

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News & Views   The present research, published in the European Journal of General Practice, examined the utility of the A1c test to identify diabetes in individuals at high risk of the condition. This involved the analysis of over 10,000 patients who received the test between 2002 and 2005. Findings revealed that within 5–8 years, 22.5% of patients developed diabetes. Patients present­ ing with A1c levels of only 5.5%, which is below the threshold for Type 2 diabetes diagnosis, presented with a significantly increased chance of developing diabe­ tes than those individuals who recorded levels

New biomarker for necrotizing enterocolitis may lead to reduced incidence of the condition in premature infants.

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