The prevalence of colorectal polyps in patients with gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 549-549
Author(s):  
Kyoung-Joo Kwon ◽  
Ki-Nam Shim ◽  
Sung-Ae Jung ◽  
Hye-Kyung Jung ◽  
Seong-Eun Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
High Risk ◽  
Medical Center ◽  
Genetic Alterations ◽  
Colorectal Polyps ◽  
Low Risk ◽  
Colorectal Adenomas ◽  
Control Group ◽  
Polyp Size ◽  
Gastric Cancers

549 Background: Gastric polyps are found frequently in various colonic polyposis syndromes. Genetic alterations of several genes occur in gastric adenomas and colorectal adenomas. However, it is unknown whether patients with gastric cancers are at higher risk for colorectal adenomas. Methods: We retrospectively reviewed the medical records in 112 patients with gastric cancers from January 2005 to December 2009. Patients who were diagnosed with gastric cancers and had colonoscopy within 6 months were compared to 220 sex and age-matched controls from 3,725 persons who underwent esophagogastroduodenoscopy and colonoscopy for screening at the Center for Health Promotion in Ewha Womans University Medical Center. High risk polyp was defined by any of the following: (1) the presence of three or more polyps; (2) polyp size at least 10mm; (3) high-grade dysplasia or adenocarcinoma confirmed by histopathologic examination. Otherwise the polyps were defined as low risk. Results: Mean age was 59 years-old and 70% was male in patients with gastric cancer. Overweight (BMI ≥ 23) was more common in control group (gastric cancer versus control: 56% and 69%, respectively, P = 0.025). Colorectal polyps were identified in 67 of 112 patients (59.8%) with gastric cancer and in 153 of 220 controls (69.5%). The prevalence of high risk polyps were numerically higher in the gastric cancer group than the control group, although not statistically significant (9% vs. 4%, P = 0.267). In contrast, the prevalence of low risk polyps were significantly frequent in the control group (91% vs. 96%, P = 0.024). The mean size and number of colorectal polyps were not different between the two groups. Adenocarcinoma was diagnosed from polyps in five patients (7%) with gastric cancer and four patients (2%) with control group (P = 0.190). Conclusions: The overall colorectal polyps, especially low risk polyps, were more prevalent in the control group. In contrast, high risk polyps and adenocarcinoma is more frequently found in patients with gastric cancer although not significant. Therefore, we suggest that colorectal polyps should be cautiously examined in patients with gastric cancer.

scholarly journals Accuracy of upper endoscopies with random biopsies to identify patients with gastric premalignant lesions who can safely be exempt from surveillance

2021 ◽  
Vol 24 (3) ◽  
pp. 680-690
Author(s):  
Michiel C. Mommersteeg ◽  
Stella A. V. Nieuwenburg ◽  
Wouter J. den Hollander ◽  
Lisanne Holster ◽  
Caroline M. den Hoed ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
High Risk ◽  
Low Risk ◽  
Premalignant Lesions ◽  
High Risk Patients ◽  
European Guidelines ◽  
Progression Of Disease ◽  
Risk Patients ◽  
Progression Risk

Abstract Introduction Guidelines recommend endoscopy with biopsies to stratify patients with gastric premalignant lesions (GPL) to high and low progression risk. High-risk patients are recommended to undergo surveillance. We aimed to assess the accuracy of guideline recommendations to identify low-risk patients, who can safely be discharged from surveillance. Methods This study includes patients with GPL. Patients underwent at least two endoscopies with an interval of 1–6 years. Patients were defined ‘low risk’ if they fulfilled requirements for discharge, and ‘high risk’ if they fulfilled requirements for surveillance, according to European guidelines (MAPS-2012, updated MAPS-2019, BSG). Patients defined ‘low risk’ with progression of disease during follow-up (FU) were considered ‘misclassified’ as low risk. Results 334 patients (median age 60 years IQR11; 48.7% male) were included and followed for a median of 48 months. At baseline, 181/334 (54%) patients were defined low risk. Of these, 32.6% were ‘misclassified’, showing progression of disease during FU. If MAPS-2019 were followed, 169/334 (51%) patients were defined low risk, of which 32.5% were ‘misclassified’. If BSG were followed, 174/334 (51%) patients were defined low risk, of which 32.2% were ‘misclassified’. Seven patients developed gastric cancer (GC) or dysplasia, four patients were ‘misclassified’ based on MAPS-2012 and three on MAPS-2019 and BSG. By performing one additional endoscopy 72.9% (95% CI 62.4–83.3) of high-risk patients and all patients who developed GC or dysplasia were identified. Conclusion One-third of patients that would have been discharged from GC surveillance, appeared to be ‘misclassified’ as low risk. One additional endoscopy will reduce this risk by 70%.

Preventive effect of trimetazidine on contrast-induced nephropathy undergoing percutaneous coronary intervention in elderly moderate and high risk diabetics stratified by mehran score

Perfusion ◽  
2020 ◽  
pp. 026765912095205
Author(s):  
Xue Zhang ◽  
Peng Zhang ◽  
Shicheng Yang ◽  
Wenyuan Li ◽  
Xiuzhen Men ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
High Risk ◽  
Serum Creatinine ◽  
Coronary Intervention ◽  
Low Risk ◽  
Control Group ◽  
Preventive Effect ◽  
Contrast Induced Nephropathy ◽  
Risk Population ◽  
Percutaneous Coronary

Background: The aim of this research was to use the Mehran risk score to classify elderly diabetics with coronary heart disease to assess the preventive effect of trimetazidine on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) in different risk population. Methods: An uncompromised of 760 elderly diabetics that went through PCI were included in this research. The patients were first divided into three groups in the light of MRS: low-risk, moderate-risk, and high-risk group, then randomized into trimetazidine group and the control group respectively. The first endpoint was the amount of CIN, which is described as a rise in serum creatinine levels by ⩾44.2 μmol/L or ⩾25% ratio within 48 or 72 hours after medication. Second endpoint included differences in creatinine clearance rate (CrCl), blood urea nitrogen (BUN), serum creatinine (Scr), cystatin-C (Cys-C), and the incidence of major adverse events after administration. Results: In the three groups, the incidence of CIN in trimetazidine and control group was 5.0% versus 4.9%(χ2 = 0.005, p > 0.05), 8.0% versus 18.0% (χ2 = 7.685, p < 0.05), 10.4% versus 27.1% (χ2 = 4.376, p < 0.05), respectively. The multivariable logistic regression result demonstrated that trimetazidine intervention was a profitable element of CIN in moderate and high-risk groups (OR = 0.294, 95% CI 0.094-0.920, p = 0.035). Conclusion: Our study confirmed that trimetazidine can be considered for preventive treatment of CIN occurrence in elderly diabetics with moderate and high-risk population, while there is no obvious advantage compared with hydration therapy in low-risk patients.

scholarly journals Salivary Cytokine Biomarker Concentrations in Relation to Obesity and Periodontitis

2019 ◽  
Vol 8 (12) ◽  
pp. 2152 ◽  
Author(s):  
Sanna Syrjäläinen ◽  
Ulvi Kahraman Gursoy ◽  
Mervi Gursoy ◽  
Pirkko Pussinen ◽  
Milla Pietiäinen ◽  
...  
Keyword(s):  
High Risk ◽  
Cumulative Risk ◽  
Normal Weight ◽  
Low Risk ◽  
Control Group ◽  
Low Grade ◽  
Periodontal Status ◽  
Tnf Α ◽  
Medium Risk ◽  
And Control

Systemic low-grade inflammation is associated with obesity. Our aim was to examine the association between obesity and salivary biomarkers of periodontitis. Salivary interleukin (IL)-1-receptor antagonist (IL-1Ra), IL-6, IL-8, IL-10, and tumor necrosis factor (TNF)-α concentrations were measured from 287 non-diabetic obese (body mass index (BMI) of >35 kg/m2) individuals and 293 normal-weight (BMI of 18.5–25 kg/m2) controls. Periodontal status was defined according to a diagnostic cumulative risk score (CRS) to calculate the risk of having periodontitis (CRS I, low risk; CRS II, medium risk; CRS III, high risk). In the whole population, and especially in smokers, higher IL-8 and lower IL-10 concentrations were detected in the obese group compared to the control group, while in non-smoking participants, the obese and control groups did not differ. IL-1Ra and IL-8 concentrations were higher in those with medium or high risk (CRS II and CRS III, p < 0.001) of periodontitis, whereas IL-10 and TNF-α concentrations were lower when compared to those with low risk (CRS I). In multivariate models adjusted for periodontal status, obesity did not associate with any salivary cytokine concentration. In conclusion, salivary cytokine biomarkers are not independently associated with obesity and concentrations are dependent on periodontal status.

scholarly journals “Don’t Eat Me” Signals of Neuroblastoma by CD47 for Immune Escape: A Novel Prognostic Biomarker

Proceedings ◽  
2018 ◽  
Vol 2 (25) ◽  
pp. 1538
Author(s):  
Safiye Aktas ◽  
Ayse Pinar Ercetin Ozdemir ◽  
Efe Ozgur Serinan ◽  
Zekiye Altun ◽  
Nur Olgun
Keyword(s):  
High Risk ◽  
Immune Escape ◽  
Prognostic Biomarker ◽  
Immunohistochemical Analysis ◽  
Risk Groups ◽  
Genetic Alterations ◽  
High Risk Group ◽  
Low Risk ◽  
P Value ◽  
Mycn Amplification

Recent studies have shown that cancer cells can deceive phagocytosing macrophage cells through the CD47 protein which gives the message “don’t eat me” or “don’t kill me” to immune components. The efficacy of anti-CD47 treatment approach was shown in cancers such as, non-small cell lung cancer, non-Hodgkin lymphoma, ovarian cancer, and breast cancer. The studies on the immunobiology of neuroblastoma has increased as monoclonal antibody based immunotherapy has shown to be effective in high-risk patients such as anti disialoganglioside. Therefore, the aim of this study was to evaluate the levels of CD47 protein expression among neuroblastoma patients with different risk groups and genetic alterations. This study included paraffin-embedded tumor tissues of 66 neuroblastoma patients (28 girls, 38 boys) with an age range of 0.5 to 108 months with a mean value of 24.9 (±23.5). According to risk classifications 21 were at low risk (31, 8%), 24 were at intermediate risk (36, 4%) and 19 were at high-risk (28, 8%) groups. These samples were evaluated for MYCN amplification, 1p36 LOH, 11q23 deletion and 17q25 gain by real-time PCR. In addition, CD47 expression status (positive or negative) was detected by immunohistochemical analysis. All data was analyzed with Chi-Square and Mann-Whitney U non-parametric tests within SPSS program, version 22.0. p value lower than 0, 5 was found statistically significant. According to the results, patients at low risk did not express CD47, while patients at high-risk group were mostly expressing CD47 (p = 0.049). MYCN amplification positive patients were expressing CD47 protein (p = 0.046). Patients without 17q25 gain were found to be expressing CD47 protein (p = 0.006). In addition, CD47 expression was increasing as age was getting higher in terms of months (p = 0.018). The findings of this study suggest that positive expression pattern of CD47 may be a poor prognostic biomarker especially in high risk 17q gain negative neuroblastoma patients.

Gastric Cancer Mortality Trends in Tuscany, Italy, 1971–2004

2008 ◽  
Vol 94 (6) ◽  
pp. 787-792 ◽  
Author(s):  
Giuseppe Gorini ◽  
Lucia Giovannetti ◽  
Giovanna Masala ◽  
Elisabetta Chellini ◽  
Andrea Martini ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
High Risk ◽  
Birth Cohort ◽  
Cancer Mortality ◽  
Cohort Effect ◽  
Low Risk ◽  
Period Effect ◽  
Mortality Trends ◽  
Risk Areas ◽  
Birth Cohort Effect

Aims, Background, and Methods In Tuscany, Italy, gastric cancer mortality has been decreasing since 1950, although with relevant geographical variability across the region. In Eastern Tuscan areas close to the mountains (high risk areas), gastric cancer mortality has been and is still significantly higher than that recorded in Western coastal areas and in the city of Florence (low risk areas). High-risk areas also showed higher Helicobacter pylori seroprevalence. Aim of this paper is to study gastric cancer mortality trends in high and low-risk areas, during the period 1971–2004, using age-period-cohort models. Results In high-risk areas, gastric cancer mortality rates declined from 61.4 per 100,000 in 1971–74 to 19.8 in 2000–2004 and in low-risk areas from 34.9 to 9.8. Mortality decline in high-risk areas was mainly attributable to a birth cohort effect, whereas in low-risk areas it was due either to a birth cohort effect or a period effect. In low- and high-risk areas, birth-cohort risks of dying decreased over subsequent generations, except for the birth cohorts born around the second world war. Conclusions Gastric cancer mortality in areas with higher H. pylori seroprevalence in Tuscany (high-risk areas) showed a predominant decline by birth cohort, in particular for younger generations, possibly due to the decrease of the infection for improvement of living conditions.

scholarly journals Racial Differences in the Biochemical Effects of Stress in Pregnancy

2020 ◽  
Vol 17 (19) ◽  
pp. 6941
Author(s):  
Paris Ekeke ◽  
Dara D. Mendez ◽  
Toby D. Yanowitz ◽  
Janet M. Catov
Keyword(s):  
High Risk ◽  
Racial Differences ◽  
Chronic Stress ◽  
Inflammatory Cytokines ◽  
Maternal Education ◽  
Risk Group ◽  
Medical Center ◽  
Low Risk ◽  
Risk Scores ◽  
Area Deprivation

Prenatal stress has been linked to preterm birth via inflammatory dysregulation. We conducted a cross-sectional study on female participants who delivered live, singleton infants at University of Pittsburgh Medical Center Magee Women’s Hospital. Participants (n = 200) were stratified by cumulative risk scores using a combination of individual factors (maternal education, diabetes, hypertension, smoking, relationship status, obesity, depression) and neighborhood deprivation scores. We hypothesized that inflammatory cytokines levels differ by risk group and race. Multiplex analyses of IL-6, IL-8, IL-10, IL-13 and TNF-alpha were run. We found that Black birthing people had more risk factors for chronic stress and had lower levels of IL-6 compared to White birthing people. When stratified by risk group and race, low-risk Black birthing people had lower levels of IL-6 compared to low-risk White birthing people, and high-risk Black birthing people had lower levels of IL-8 compared to high-risk White birthing people. Higher area deprivation scores were associated with lower IL-6 levels. Our results suggest that the relationship between chronic stress and inflammatory cytokines is modified by race. We theorize that Black birthing people encounter repetitive stress due to racism and social disadvantage which may result in stress pathway desensitization and a blunted cytokine response to future stressors.

Platelet Functions and Risk Prognosis in Myelodysplastic Syndromes,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3806-3806
Author(s):  
Nora V. Butta ◽  
Mónica Martín Salces ◽  
Raquel de Paz ◽  
Elena G. Arias Salgado ◽  
Ihosvany Fernández Bello ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
High Risk ◽  
Myelodysplastic Syndromes ◽  
Surface Expression ◽  
Low Risk ◽  
Control Group ◽  
Platelet Surface ◽  
High Risk Patients ◽  
Fibrinogen Receptor ◽  
Risk Patients

Abstract Abstract 3806 The myelodysplastic syndromes (MDS) are a heterogenous group of clonal stem cell disorders with peripheral cytopenias and increased incidence of leukemic transformation. The prognosis of MDS is determined by several factors, including the presence of specific cytogenetic abnormalities, the percentage of blastoid cells in bone marrow and peripheral blood, the number of affected cell lineages, and transfusion dependency. The most commonly used risk stratification system is the International Prognostic Scoring System (IPSS). This score divides patients into a lower risk subset (low and intermediate-1) and a higher risk subset (intermediate-2 and high). Patients with MDS may have hemorrhagic complications with serious outcomes that are among the major causes of death in this population. These bleeding episodes that are often related to thrombocytopenia also occur in MDS patients with normal platelet count. The aim of this work was to study functional characteristics of platelets in MDS patients and their relationship to risk evaluated as indicated by IPSS. Eighty diagnosed MDS patients risk-stratified according to IPSS were included: 40 with low-risk, 29 with intermediate-1-risk (I-1), 8 with intermediate-2-risk (I-2) and 3 with high-risk. Eighty healthy donors were included as control group. Platelet-related primary haemostasis was evaluated with an automated platelet function analyzer (PFA-100®, Siemens Healthcare Diagnostics). Samples of citrated blood were aspirated under a shear rate of 4,000–5,000/s through a 150-μm aperture cut into a collagen-ADP (COL-ADP) or collagen-epinephrine (COL-EPI) coated membrane. The platelet haemostatic capacity is indicated by the time required for the platelet plug to occlude the aperture (closure time, CT), which is expressed in seconds. Platelet activation was determined through FITC-PAC-1 (a mAb that recognizes activated conformation of fibrinogen receptor) and FITC-P-selectin mAb binding to quiescent and 100 μM TRAP activated platelets by flow cytometry. Surface expression of fibrinogen receptor (αIIb and β3 subunits) was determined by flow cytometry with specific mAbs. Apoptosis was determined by flow cytometry analysis through FITC-annexin V binding to platelet membrane phosphatidylserine (PS) exposed in basal conditions. I-2 and high-risk patients were gathered together in a high-risk group in order to analyze experimental results. Statistical analysis was performed with one-way ANOVA and Tukey test. CTs obtained with COL-EPI and COL-ADP cartridges in controls and low risk patients were similar and significantly shorter than CTs observed in I-1-risk and high-risk MDS patients (p<0.05). Platelets from all MDS patients showed a reduced capability for being activated by 100 μM TRAP. This impairment was more evident in I-1-risk and high-risk patients: PAC-1 binding, in arbitrary units (AU), was 11368±1017 in controls; 7849±789 in low-risk MDS (p<0.05); 4161±591 in I-1-risk MDS (p<0.01 versus control and p<0.05 versus low-risk) and 492±184 in high-risk MDS (p<0.01 versus control and p<0.05 versus low-risk). The platelet surface expression of P-selectin induced by 100 μM TRAP was also reduced: 5102±340 AU in controls, 3318±400 AU in low-risk MDS (p<0.05); 1880 ±197 AU in I-1-risk MDS (p<0.05 versus control and versus low-risk), and 1211±130 AU in high-risk MDS (p<0.05 versus control and versus low-risk). Diminished responses to TRAP were not due to a reduction in surface expression of fibrinogen receptor in platelets from MDS patients. Platelets from MDS patients expressed more PS than controls under basal conditions. Mean fluorescence values for FITC-annexin binding were: 383±16 in controls; 444±21 in low-risk (p<0.05); 575±52 in I-1-risk MDS (p<0.05 versus control and versus low-risk); 611±17 in high-risk MDS (p<0.05 versus control and versus low-risk). Our results indicated that platelets from MDS patients had less ability to be activated and were more apoptotic than control ones. These dysfunctions were more pronounced when the risk of the disease was higher according to IPSS. Disclosures: No relevant conflicts of interest to declare.

Overuse of DVT Prophylaxis in Medical Inpatients

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5563-5563 ◽  
Author(s):  
Jing Deng ◽  
Lisa Thomas ◽  
Huijing Li ◽  
Elvin Varughesekutty ◽  
Qi Shi ◽  
...  
Keyword(s):  
Risk Assessment ◽  
High Risk ◽  
Conflicts Of Interest ◽  
Medical Center ◽  
Low Risk ◽  
Risk Of Bleeding ◽  
Dvt Prophylaxis ◽  
Increased Risk ◽  
Medical Inpatients ◽  
Nonsurgical Patients

Abstract Introduction: Unfractionated heparin (UFH), or low-molecular-weight heparin (LMWH), is commonly used with mechanical prophylaxis as an anticoagulant to reduce the risk for venous thromboembolism (VTE). However, overuse of these prophylaxes can increase the risk of bleeding, heparin-induced thrombocytopenia (HIT) and associated medical cost. PURPOSE: The aim of this study is to determine the incidence of DVT prophylaxis among hospitalized nonsurgical patients in a community medical center. To evaluate the use of the prophylaxes as described above, the investigators collected data on medical inpatients and addressed how to avoid overuse. Method: A retrospective inpatient chart review of 100 general internal medicine patients analyzed data using Padua Prediction Score as the risk estimate for deep venous thrombosis (DVT). High risk for VTE was defined by a cumulative score >=4 and low risk was a score <4. Only patients at increased risk for DVT but not at high risk for bleeding qualified for heparin treatment. Results: A total of 100 patients were surveyed. 54/100 (54%) patients had low risk of DVT with score < 4, and of those 29/54 (53.7%) patients received DVT prophylaxis with SCDs and/or heparin, and 17/54 (31.5%) patients were treated with heparin. All 46 patients with score >= 4 were treated with DVT prophylaxis of which 10 patients were only treated with heparin and 36 patients were given both mechanical and chemical prophylaxis. Collectively, 53.7% of the patients received treatment with DVT prophylaxis (p < 0.001, Chi-Square test). Discussion: In hospital settings, physicians want to avoid DVT or PE so they tend to consider patients as being at moderate risk for DVT without using any method of DVT risk assessment. This leads to unnecessary overuse of DVT prophylaxis on patients and may increase the risk of bleeding and injury. Conclusion: Our data suggests that there DVT prophylaxis including UFH and LMWH was over prescribed among patients with who had marginal risk for DVT in hospitalized nonsurgical patients in a community medical center. Clinical implications: To avoid the overuse of DVT prophylaxis, physicians need to follow guidelines. Education and inclusion of the guidelines in EHRs of information on VTE risk assessment for hospitalized medical patients upon admission may reduce unneeded DVT prophylaxis and the risk of bleeding and costs associated with additional care needs. Disclosures No relevant conflicts of interest to declare.

Five year follow up of a phase II study of cytotoxic immunotherapy combined with radiation in newly diagnosed prostate cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4635-4635 ◽  
Author(s):  
L. K. Aguilar ◽  
B. Teh ◽  
W. Mai ◽  
J. Caillouet ◽  
G. Ayala ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Controlled Trial ◽  
Pathologic Complete Response ◽  
Low Risk ◽  
Control Group ◽  
Newly Diagnosed ◽  
Kinase Gene ◽  
Cell Immunity

4635 Background: In the U.S. there are about 70,000 annual prostate cancer recurrences. The purpose of this study is to evaluate a product to decrease incidence of recurrence. This study is based on objective clinical responses in Phase I studies with AdV-tk (ProstAtak™, Advantagene, Inc) as monotherapy in recurrent disease and preclinical data demonstrating synergy between AdV-tk and radiation. AdV-tk is an adenoviral vector expressing the herpes thymidine kinase gene delivered to the prostate via TRUS-guided injection followed by 14 days of oral prodrug. The mechanisms of function involve direct tumor cytotoxicity, local elicitation of danger signals, recruitment and activation of antigen presenting cells and stimulation of systemic anti-tumor T-cell immunity. Method: AdV-tk was evaluated in combination with radiation in 66 newly diagnosed patients: 33 low risk (Arm A, PSA <10, Gleason <7, and T1c-T2a) and 33 intermediate-high risk (Arm B, PSA ≥10, Gleason ≥7, or T2b-T3). Arm A received two treatments with AdV-tk, immediately before and 14 days into radiation. Arm B received an additional treatment at initiation of androgen deprivation therapy. Results: Two surrogate and one definitive end-point were evaluated. Frequency of patients in Arm A with PSA nadir ≤0.2 ng/ml was 71% vs 56% in a control group of concurrent patients without AdV-tk. The two-year pathologic complete response (pCR) rate by sextant biopsy was 90% in Arm A and 94% in Arm B, compared to an expected range of 70–73%. Freedom from failure (FFF) after 60 month median follow up is 100% for Arm A and 90% for Arm B (95% for intermediate, 75% for high risk) vs best reported results of 79–90% for low risk and 48–79% for intermediate-high risk patients. The three failures in Arm B occurred within months after treatment leading to a Kaplan-Meier curve that plateaus at 90% beyond year 3. This is notably different than previous reports in which the curves continue to drop beyond year 5. Conclusion: These results suggest that AdV-tk combined with radiation therapy may significantly reduce the recurrence rate in patients with prostate cancer, particularly in patients with intermediate-high risk disease. A randomized controlled trial is warranted. [Table: see text]

The MIRACLE trial: A randomized, controlled trial comparing green tea extract versus placebo for the prevention of metachronous colon adenomas in a screening population.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. TPS786-TPS786 ◽  
Author(s):  
Thomas Jens Ettrich ◽  
Julia Stingl ◽  
Rainer Muche ◽  
Katrin Claus ◽  
Baerbel Reiser ◽  
...  
Keyword(s):  
Green Tea ◽  
Controlled Trial ◽  
Epigallocatechin Gallate ◽  
Genetic Alterations ◽  
Colorectal Polyps ◽  
Green Tea Extract ◽  
Colorectal Adenomas ◽  
Tissue Samples ◽  
Increased Risk ◽  
Tea Extract

TPS786 Background: Prevention of colorectal cancer is a major health care issue. After polypectomy there is an increased risk of polyp recurrence and various means of chemoprevention have been tried to prevent this. NSAIDs have been shown to be effective but confer side effects such as gastrointestinal bleeding. Nutraceuticals such as polyphenols from tea plants have demonstrated remarkable therapeutic and preventive effects in molecular, epidemiological and some clinical trials. However, their value in preventing colorectal polyps has not been demonstrated in a large, randomized trial. The beneficial safety profile of decaffeinated green tea extract and accumulating evidence of its cancer preventive potential justify and require, in our view, a validation of this compound for the nutriprevention of colorectal adenoma. Good accessibility and low costs might render this neutraceutical a top candidate for wider use as nutritional supplement in colon cancer prevention. Methods: Randomized, double blinded, placebo-controlled, multicenter trial. After a one month run-in period with verum, 918 patients (age: 50-80 years) who have undergone polypectomy within the last 6 months will be randomized to receive either decaffeinated green tea extract (containing 150 mg epigallocatechin gallate (EGCG) two times daily) or placebo over a period of three years. Primary outcome: Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous, serrated lesions) at the 3 year follow-up colonoscopy. Secondary outcomes: Occurrences, number, localization, size and histological subtypes of adenomas, frequency of colorectal carcinoma. In addition, genetic and biochemical biomarkers in blood samples and genetic alterations (Ras, B-raf, microRNAs) in tissue samples of adenomas will be analyzed (biobanking subprojects). Additionally, nutrikinetics and nutrigenetics of EGCG and other catechins will be assessed in healthy volunteers. Patient recruitment has started in November 2011. At September 2014, 785 patients were recruited and 651 patients were randomized. We expect the last patient out in Spring 2018. (Trial identifier NCT01360320) Clinical trial information: NCT01360320.

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