Objective Although duplex ultrasound is the standard for the diagnosis of lower extremity deep venous thrombosis (LE-DVT), imaging is not always available. The use of D-dimer can exclude (high-sensitivity), but not rule in (low-specificity) LE-DVT. Previously, we demonstrated that soluble P-selectin (sP-sel) in combination with the Wells score, establishes the diagnosis of LE-DVT with a specificity of 96% and a positive predictive value of 100%. In order to validate our previous results, we applied the model to a separate but similar patient cohort. Additionally, we analyzed the role of biomarkers for diagnosing upper extremity DVT (UE-DVT). Methods Between April 2009 and March 2012, all patients presenting for a duplex ultrasound exam with concern of DVT were screened. Demographics, clinical data, D-dimer, sP-sel, C-reactive protein, a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13, and von Willebrand factor levels were prospectively collected in 279 patients (234 LE-DVT, 45 UE-DVT). Continuous and categorical variables among patients with DVT were compared with patients without DVT. The diagnostic sensitivity, specificity, positive predictive value, and negative predictive value were then calculated using our previously derived cut points to rule in or exclude DVT. Results Among 234 patients evaluated for LE-DVT, 112 (48%) patients had a confirmed LE-DVT with significant differences in all biomarkers. When Wells score ≥2, sP-sel could rule in LE-DVT with a specificity of 97.5% and a positive predictive value of 91%, which was more accurate than Wells score ≥2 and D-dimer (specificity, 65%; positive predictive value, 69%). When Wells score was <2, D-dimer was superior to sP-sel for excluding the diagnosis of LE-DVT (sensitivity, 98%; negative predictive value, 95% vs sensitivity, 91%; negative predictive value, 79%). The use of additional biomarkers did not increase accuracy. Had imaging not been available, we could have correctly ruled in or ruled out LE-DVT in 29% (67/234) of patients. The use of sP-sel in UE-DVT was nondiagnostic. Conclusions We demonstrate that when Wells score ≥2, sP-sel is an excellent biomarker to rule in LE-DVT. Different from our previous study, D-dimer and a Wells score <2 was most sensitive at excluding a diagnosis of LE-DVT. Combined, Wells score, sP-sel, and D-dimer can both rule in and exclude LE-DVT in approximately one-third of patients.
Introduction:Head and neck squamous cell carcinoma (HNSCC) has traditionally been known as a disease of older men with a history of tobacco and alcohol abuse. Recently, though, the incidence of this disease has been increasing in younger patients, especially women. This subset includes pregnant women. The purpose of this study was to investigate HNSCC in pregnant women, a population that represents a rare but therapeutically challenging patient subset. Methods: After obtaining IRB approval, the EMERSE search engine was used to identify all women treated at the University of Michigan from 1985-2010 who developed HNSCC during pregnancy. Four patients were identified who were diagnosed with oral tongue lesions between 1997 and 2007. Biomarker expression was assessed by immunohistochemistry and HPV was assessed by multiplex PCR/Mass spectrometry analysis.
Objective To investigate oral cancer in pregnant women, a rare but therapeutically challenging patient subset. Methods After IRB approval, an EMERSE search was used to identify all women treated at the University of Michigan from 1998–2010 with head and neck squamous cell carcinoma (HNSCC) during pregnancy. This identified four patients with tongue cancer. Biomarkers and HPV were assessed by immunohistochemistry and multiplex PCR/Mass spectrometry, respectively. Results Two patients responded well to therapy and are alive more than 10 years after diagnosis; two died of disease. All tumors overexpressed EGFR and Bcl-xL, three of four overexpressed c-Met, both tumors that progressed overexpressed p53. All tumors were negative for HPV, p16, ER, PR, and HER-2. Conclusions Biomarkers of aggressive tumors (high EGFR, Bcl-xL, c-Met; low p53) did not correlate with outcome. Additional studies are needed to determine whether perineural invasion, delay in diagnosis, and p53 overexpression are factors related to poorer survival.
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