A large body of evidence indicates that Helicobacter pylori is involved in the pathogenesis of chronic gastritis and peptic ulcers. Several techniques are currently used for detecting H. pylori. Recently the immunohistochemical method was introduced for rapid detection of H. pylori. To compare the result of the immunohistochemical method with those obtained by microbiologic methods, we glean formalin fixed, paraffin embbeded gastric and duodenal biopsy specimens from 85 patients with upper gastrointestinal symptoms. We set fifty cases which H. pylori was cultivated and identified by Gram stain as Group I, and thirty-five cases without H. pylori in Gram stain and culture as Group II. The results were as follows. 1) The sensitivity and the specificity of immunohistochemical method were 94% and 80% compared with the microbiologic method. Positive and negative predictive value of the immunohistochemical method were respectively 87% and 90%. However, in seven cases of Group II, H. pylori were identified by immunohistichemical method. 2) Immunohistochemical staining exhibited bacteria that were present in the mucus layer, the surface of the gastric mucosa and metaplastic gastric epithelium in duodenum. With reference to the distribution and density of H. pylori in Group I and II, a significant correlation existed between microbiologic results and bacterial load of the biopsy specimen (p<0.01). 3) Chronic inflammation of gastric biopsies were seen in all 45 H. pylori-positive cases(100%) and 16 out of 19 H. pylori-negative cases(84%). The degree of chronic inflammation was more severe in positive cases than negative cases. Activity of inflammation was seen 98% of H. pylori-positive cases and 16% of H. pylori-negative cases. Intestinal metaplasia was seen 40% of H. pylori-positive cases and 58% of H. pylori-negative cases. Lymphoid follicles and aggregates were seen in 47%(27 cases) of H. pylori-positive cases. Among 47%, cases with lymphoid follicles were 9%(4 cases) and cases with lymphoid aggregates were 38%(17 cases). In H. pylori-negative cases, lymphoid follicles and aggregates were seen in 16%(3 cases). It is possible to obtain samples from most of the individuals who underwent the endoscopy in Korea. And this method is simple, rapid and sensitive. We conclude that the immunohistochemical method is another useful diagnostic tool for detection of Helicobacter pylori.
Predictive Value of Tests ; Biopsy

PURPOSE: In the present study, we identified the pre-operative predictive factors of insignificant prostate cancer and we analyzed their diagnostic accuracy. MATERIAL AND METHODS: Of a total 343 patients who had undergone radical prostatectomy, 33 patients(9.6%) were diagnosed with insignificant cancer that was characterized by a total cancer volume < or=0.5cc, a Gleason score (GS)< or=6, a T stage< or=2c and no positive surgical margin. We found the statistically significant factors after comparing of preoperative clinico- pathological findings between two groups and determined the diagnostic accuracy of the identified predictors. RESULTS: Of several factors, prostate-specific antigen(PSA) level(p=0.04, odds ratio(OR)=4.3 3.589< or=95%confidence interval(CI)< or=5.692), PSA density(PSAD)(p=0.01, OR=6.6, 2.115< or=95%CI< or=278.826), biopsy GS(p=0.03, OR=4.6, 1.114< or=95%CI< or=12.568) and volume of the largest cancer(p=0.02, OR=5.6, 2.471< or=95%CI< or=9.725) were analyzed as independent predictors of insignificant cancer. The volume of the largest cancer was the most precise predictor(AUC=0.791), followed by the PSAD (AUC=0.748) and the PSA level(AUC=0.677) in the ROC (receiver operating characteristic) curve analysis. The sensitivity, specificity and positive predictive value for predicting insignificant cancer were 10.3%, 63.7% and 12.8% at a PSA level of 10ng/ml, and 44.8%, 16.8% and 26.3% at a PSAD of 0.15ng/ml/ml, and 13.8%, 53.8% and 14.2% at a volume of the largest cancer of 50%, respectively. Even with using a combination of these three factors as well as a biopsy GS< or=6, only 53% of insignificant prostate cancer could be predicted preoperatively. CONCLUSIONS: In our study, PSA level, PSAD, biopsy GS and volume of the largest cancer were identified as predictors of insignificant cancer in spite of their unsatisfactory diagnostic accuracy.
Predictive Value of Tests ; Biopsy

Purpose: The adenosine-triphosphate-based chemotherapy response assay (ATP-CRA) is a well-documented and validated technology for individualizing chemotherapy in cancer patients. We evaluate the feasibility of ATP-CRA in colorectal cancer patients. This study will illustrate the assay's success rate, the mean coefficient of variation, and the turnaround time as a validation tool for a chemosensitivity test. Methods: A total of 118 patients, treated by surgery between June 2004 and September 2005 were evaluated for chemosensitivity to seven anticancer agents (5-fluorouracil (5-FU), oxaliplatin, irinotecan, epirubicin, etoposide, gemcitabine, and paclitaxel) by using an ATP-CRA. To allow a comparison between samples, we calculated the chemosensitivity index (CI) based on the percentage cell death rate (CDR, %) at each test drug concentration. Results: The assay success rate was 85.5% (118/138), and the mean coefficient of variation, indicating intra-assay error level, was 9.2%. CDR measured at a therapeutic peak plasma concentration ranged from 0% to 93.6% with a median of 31.0% for 5-FU, 28.5% for oxaliplatin, 34.0% for irinotecan, 25.0% for epirubicin, 21.0% for etoposide, 22.0% for gemcitabine, and 25.2% for paclitaxel. According to the CI, the most sensitive drug varied from patient to patients 10.9% for 5-FU, 10.9% for oxaliplatin, 24.7% for irinotecan, 11.8% for epirubicin, 22.4% for etoposide, 1.1% for gemcitabine, and 23.3% for paclitaxel. Conclusions: Our data suggest that the ATP- CRA is a feasible in-vitro chemosensitivity test in colorectal cancer and that patients show heterogeneous chemosensitivity. A study evaluating the predictive value of ATP-CRA directed therapy is needed to determine the clinical usefulness of the test.
Mortality ; Predictive Value of Tests

PURPOSE: Proteinuria is the hallmark of glomerular injury and results from alterations in glomerular permeability. The permeability of diseased glomerulus has been estimated by selectivity of proteinuria. Recently, some authors showed a significant relationship between selectivity of proteinuria and tubulointerstial damage. The present study examines the role of protein selectivity as a prognostic marker in patients with IgA nephropathy and its correlation with other prognostic indices. METHODS: The selective proteiuria index of 81 cases with IgA nephropathy diagnosed between 1990 and 2000 were reviewed, and each case was subclassified using the following : highly selective(SPI0.2). The mean age of the patients was 27+/-15 years with a follow-up period of 38+/-24 months. Six patients had highly selective proteinuria, thirty three patients had moderately selective proteinuria, and forty two patients had nonselective proteinuria. RESULTS: 1) A significant relationship was found between the SPI and Haas subclasess(p=0.01). With respect to clinical presentaion, hypertension(0, 4, 11 cases, p<0.05), proteinuria(0.52+/-0.35, 1.85+/-1.55, 2.79+/-2.51 g/day, p<0.05) were significant correlation.2) Chronic renal failure was significantly higher in patients with nonselective proteinuria in comparison with patients with selective proteinuria(p<0.05).3) Markers of renal failure by the Cox proportional hazards model were Cr(Exp(B)=4.2, p<0.001), Ccr (Exp(B)=2.1, p<0.05), SPI(Exp(B)=1.7, p<0.05), hypertension(Exp(B)=1.6, p<0.05). 4) In 28 patients of IgA nephropathy with nephrotic syndrome, 9 patients were moderately selective, 19 patients were nonselective. The response to therapy, evaluated retrospectively, was 67% and 16% in moderate and nonselective proteinuria(p=0.01). CONCLUSION: There is a significant relationship between selectivity of proteinuria and clinical para meters. Moreover, the selectivity of proteinuria has a predictive value on functional outcome.
Predictive Value of Tests

BACKGROUND: Alopecia areata usually has a complete recovery rate in most patients, but others eventually develop the severe chronic form. Unfortunately, its course and response rates are variable and unpredictable. OBJECTIVE: To identify patient and treatment factors predictive of therapeutic success and to develop a practical model for predicting patient response. METHODS: The medical records of 189 patients with alopecia areata from 1998 to 2001 at the Department of Dermatology, Chungnam National university hospital were reviewed. Most patients were treated by corticosteroids (topical, intralesional, and systemic). RESULTS: Variables independently associated with clinically significant regrowth were the duration between initiation of therapy, baseline extent of alopecia areata. 1. Both partial response and no response (PR+NR): long duration between initiation of therapy (>3month; especially >12 months), baseline extent of alopecia areata (>25%; especially 100%- alopecia totalis and universalis) and male patients. 2. Duration between initiation of therapy: Cosmetically acceptable hair regrowth was obtained in 6% of patients over 12 months, 57% with 4 to 12 months and 97% 0 to 3 months. So, it is better to start treating within 3 months; and at least within 12 months. 3. Baseline extent of alopecia areata: Cosmetically acceptable hair regrowth was obtained in 27% of patients with alopecia totalis/universalis, 64% with 26 to 99%, and 94% with below 25% alopecia areata. So, it showed a good response when below 25 %, but a poor response at above 25%, specially for 100%. CONCLUSION: These findings suggest that when the duration between initiation of therapy (>12 months) and the baseline extent of alopecia areata increases, the therapeutic effect decreases. A predictive model (decision tree) has been developed to assist with patient prognostication and counseling.
Male ; Humans ; Predictive Value of Tests

PURPOSE: The purpose of this study was to evaluate silver in situ hybridization (SISH) as an effective test to identify HER2 gene amplification in patients with breast cancer. METHODS: A systematic literature review was used to evaluate the effectiveness of SISH. The literature review covered from October 27, 2009 to December 1, 2009, and eight domestic databases including KoreaMed and foreign databases including Ovid-MEDLINE, EMBASE, and Cochrane Library were used. Keywords, such as 'silver in situ hybridization' and 'SISH', were used to search 63 documents. Ten studies regarding the evaluation of diagnostics were included in the final evaluation. The Scottish Intercollegiate Guidelines Network (SIGN) tool was used by two evaluators to independently evaluate the quality of the ten studies. RESULTS: A total of ten studies (nine diagnostic evaluation studies and one correlation study) were identified to evaluate SISH. The effectiveness of this test was evaluated based on diagnostic accuracy, concordance rate, and correlation with fluorescence in situ hybridization (FISH) results. The sensitivity of SISH was 0.81-1.00, and the specificity was 0.82-1.00. The positive predictive value was 0.95-1.00, negative predictive value was 0.81-1.00, and the test accuracy was 0.90-1.00. The concordance rate of SISH was 87.0-100% and two studies reported a correlation with FISH results. The body of evidence as a whole suggests a Grade D for SISH. CONCLUSION: SISH is a safe and useful procedure in patients with breast cancer and at least grade D evidence based on existing positive studies.
Predictive Value of Tests ; Breast Neoplasms

OBJECTIVE: To assess diagnostic accuracy of the transvaginal ultrasonography and confirm the clinical safety as a final diagnosis in the asymptomatic ectopic pregnancy. METHODS: Total 58 women which were suspected with ectopic pregnancy were recruited during 1 year period. Women without sonographic evidence of the intrauterine gestational sac with serum beta-hCG level beyond 1,500 mIU/ml or gestational periods beyond 37 days were included (n=44), and women with acute symptom were excluded (n=14). We performed the laparoscopy and compared them with the ultrasonographic findings. We regarded the cases with accordance between two findings as an accurate diagnosis, and calculated diagnostic accuracy. All surgical specimens were confirmed by the pathological examination. RESULTS: Of 44 subjects, we suspected ectopic pregnancy by ultrasonography in 42 patients and classified as right fallopian tube (20 cases), left fallopian tube (15 cases), right interstitial (3 cases), left interstitial (4 cases), normal finding (2 cases). Of 42 cases, 41 cases were confirmed as an ectopic pregnancy by laparoscopical and pathological examination. There were two cases of inaccurate diagnosis, in one case, suspected site was not concordant, in another case, ectopic pregnancy focus was not identified in laparoscopy. In 2 cases with normal ultrasonographic findings, any other findings suspicious of ectopic pregnancy were not identified in laparoscopy. By 2X2 contingency table analysis, sensitivity, specificity, positive predictive value, negative predictive value of the transvaginal ultrasonography for diagnosis of the ectopic pregnancy were 100%, 50%, 98%, 100%, respectively. CONCLUSION: Diagnostic capability of the transvaginal ultrasonography in the ectopic pregnancy was very powerful and reliable, and sonographical diagnosis may replace the diagnostic laparoscopy if medical treatment is intended.
Pregnancy ; Female ; Humans ; Predictive Value of Tests

BACKGROUND: Renal cell carcinoma (RCC) is notorious for its high metastatic potential, and 30% of RCC patients present with metastatic disease at the initial presentation and 50% of them will develop metastasis or recurrence after radical surgery. METHODS: In an attempt to identify the best predictive marker(s) for metastasis in patients with clear cell RCCs (CRCCs), we examined the expression patterns of 7 metastasis/prognosis-related markers by constructing a tissue microarray including primary CRCC specimens from 30 metastatic and 60 nonmetastatic CRCCs. The markers we studied were Ki-67, MUC1, CD44s, PTEN, gelsolin, CA9 and p53. RESULTS: The expressions of Ki-67, PTEN, CD44s, gelsolin and p53 were increased, whereas those of MUC1 and CA9 were decreased in the metastatic CRCCs compared with the non-metastatic CRCCs. The receiver operating characteristic curve-area under the curve (AUC) value of Ki-67 was 0.671, which was the highest among the 7 markers. The optimal cut-off value, sensitivity and specificity of the Ki-67 expression were 1.67%, 86.7% and 41.7%, respectively. CONCLUSIONS: These results demonstrate that the Ki-67 expression was increased in metastatic CRCCs, and it had the highest predictive value among the 7 markers. This suggests that Ki-67 could be an excellent predictive marker for metastasis in CRCC patients.
Sensitivity and Specificity ; Predictive Value of Tests ; Neoplasm Metastasis

PURPOSE: In breast cancer, the single most important prognostic indicator is the axillary nodal status of the metastasis. This study was designed to discern the accuracy of sentinel node biopsy using radioactive material for the prediction of axillary nodal status. METHODS: The study group was selected from the Department of Surgery at Yonsei University Yongdong Severance hospital, and comprised 54 patients diagnosed with breast cancer with clinical stages I or II from Nov. 1998 to May. 1999. We performed lymphoscintigraphy and gamma-probe with 99mTc-antimony trisulfide colloid for the detection of sentinel nodes. The radiotracer was injected peritumorily 2 hours prior to the operation. During, surgery and after the sentinel node biopsy was performed, level I and II axillary lymph node dissection was completed. The sentinel node was divided into 3 pieces evenly. One piece was tested for frozen section diagnoses and the others were fixed for H&E staining and immunohistochemistry (IHC) using cytokeratin antibody to detect metastasis. RESULTS: The mean number of the sentinel nodes was 1.59. The detection rate of the sentinel node was 94.4% (51/54). Among 35 patients with negative sentinel nodes on frozen section, 4 patients (11.4%) demonstrated tumor metastasis on both permanent serial H&E sections and IHC using cytokeratin. Of the 31 patients with negative sentinel node by permanent serial section, 4 patients displayed metastasis in nonsentinel axillary nodes. These results revealed that thesensitivity of the sentinel node biopsy was 83.3% and the negative predictive value was 81.1%. The false negative rate of the sentinel node biopsy was 16.7% with the permanent H&E and IHC section and 33.3% with the frozen section. In particular, in cases with tumors less than 2 cm, the sensitivity was 100% in frozen section as well as permanent section. CONCLUSION: A combination of preoperative lymphoscintigraphy and gamma probe-guided methods achieves high success rates in the identification of sentinel nodes. Multiple serial sections and IHC of the nodes are required to detect the micrometastasis of the sentinel nodes. The sentinel node biopsy is significantly accurate and may be considered as an alternative to replace the routine axillary node dissection, particularly in T1 breast cancer patients.
Predictive Value of Tests ; Biopsy ; Breast Neoplasms

Background: The fetus having risk for Down sydrome (DS) can be detected early by AFP, \u03b2hCG in maternal serum to detect the fetus having risk of Down sydrome. Objectives: Determining values of AFP, \u03b2hCG in maternal serum to detect the fetus having risk of DS. Subjects and method: Determining the concentration of AFP, \u03b2hCG in maternal serum of 591 pregnant with fetus \ufffd?12 weeks to detect the fetus having DS screening risk. The fetus are diagnosed DS by analysing chromosome from amniocyte and monitor up to the neonate. Then, finding out association between DS fetus and AFP, \u03b2hCG in maternal serum. Results: 75/591 of subjects screened were screen positive, 6/7 DS fetus associated withscreen positive, (cut off AFP \ufffd?0,75 MoM, \u03b2hCG \ufffd?2,2 MoM). Detection rate (DR) was 85,71%; false positive rate (FDR): 11,81%. Only base on AFP: DR was 71,43%; FDR: 11,81%. Only base on \u03b2hCG DR was 28,57%; FDR: 0,51%. Conclusion: DR base on AFP is higher than base on \u03b2hCG. If combining AFP and \u03b2hCG, DR is the highest. AFP is important role in screening DS fetus.
Down Syndrome/ diagnosis ; Predictive Value of Tests ; Prenatal Diagnosis ; Pregnancy ;