Endoscopic Therapy of Early Cancer in Barretts Esophagus

Barretts 食管早期癌的内镜治疗

• 批准号: 7648125
• 负责人: KENNETH K WANG
• 金额: $ 31.37万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-16 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7648125
• 关键词: Achievement; Acids; Adenocarcinoma; Advanced Malignant Neoplasm; Aftercare; Aneuploidy; Area; Asia; Barrett Esophagus; Biological Markers; Biopsy; Cancer Patient; Cancerous; Caucasians; Caucasoid Race; Chronic; Clinical; Clinical Research; Control Groups; Country; Cytological Techniques; Cytology; Development; Diagnosis; Diagnostic; Disease; Dyspepsia; Dysplasia; Early Diagnosis; Early treatment; Endoscopy; Epithelial; Epithelium; Esophageal Adenocarcinoma; Esophagus; Excision; Flow Cytometry; Fresh Tissue; Future; Gastroesophageal reflux disease; Gastrointestinal Neoplasms; Guidelines; Health Status; Incidence; Loss of Heterozygosity; Malignant Neoplasms; Malignant Squamous Cell Neoplasm; Malignant neoplasm of esophagus; Matrix Metalloproteinases; Measures; Metaplastic; Methodology; Methods; Morbidity - disease rate; Mucous Membrane; Neoplasms; Operative Surgical Procedures; Outcome; Patients; Performance; Pharmaceutical Preparations; Phase II Clinical Trials; Photochemotherapy; Ploidies; Population; Population Analysis; Premalignant; Progressive Disease; Quality of life; Quality-of-Life Assessment; Questionnaires; Radiation therapy; Randomized; Recurrent Malignant Neoplasm; Reflux; Relative (related person); Research Personnel; Resected; Residual state; Risk; Role; SF-36; Screening procedure; Series; Sorting - Cell Movement; Specimen; Staging; TP53 gene; Techniques; Therapeutic; Tissue Banking; Tissue Banks; Tissues; Tumor Cell Invasion; United States; Vascular Endothelial Growth Factors; base; cancer recurrence; cancer risk; chemotherapy; design; gastrointestinal function; health related quality of life; male; minimally invasive; novel; primary outcome; programs; prospective; response; success; treatment strategy; tumor; tumor progression

DESCRIPTION (provided by applicant): Esophageal adenocarcinoma is the most rapidly increasing cancer among Caucasian males in Western countries. It is associated with Barrett's esophagus, a pre-malignant condition, for which current guidelines recommend both endoscopic screening and surveillance. This has resulted in increasing numbers of early adenocarcinomas being diagnosed that are potentially endoscopically curable. Although surgical resection and chemoradiation are effective in eliminating cancer, the morbidity from these treatments is substantial. The endoscopic treatment of early cancer includes endoscopic mucosal resection and photodynamic therapy. Endoscopic mucosal resection can remove the cancer containing tissue and permits accurate histological determination of tumor depth and extent. However, mucosal resection usually does not removal all of the premalignant mucosa and there has been a high incidence of cancer recurrence in the residual non-cancerous Barrett's mucosa. Our hypothesis is that endoscopic therapy can treat early esophageal adenocarcinoma. The primary aim of the study will be to determine if photodynamic therapy will be needed in addition to endoscopic mucosal resection to increase cancer free survival in patients with early adenocarcinoma. The study will involve one hundred patients with early esophageal adenocarcinoma that can be completely removed by mucosal resection. After removal of the cancer, these patients will be randomized to receive either photodynamic therapy or careful observation. A secondary aim of this study will be to determine if biomarkers that predict cancer progression including aneuploidy, loss of heterozygosity for p53 or p16 performed using novel cytological techniques can be correlated with flow cytometry performed on tissue. The third aim of this study will be to determine if these known biomarkers can be used to identify the patients that have progressive neoplasia and benefit from additional therapy. In addition to these known biomarkers, tissue will be stored from these patients to determine if other biomarkers might be useful in defining appropriate treatment groups. A fourth aim of this study will be to determine the patient's quality of life after these treatments since this is an important reason for choosing endoscopic therapy. General and disease specific health related quality of life assessments would be performed on a quarterly basis to determine their health status before, during and after treatment. The achievement of these specific aims is needed to help design future trials to determine the best strategy for treatment of early esophageal adenocarcinoma. Diagnostic and therapeutic techniques developed in this study can be applied to other gastrointestinal tumors.

描述（由申请人提供）：食管腺癌是西方国家中高加索男性中癌症最快的癌症。它与Barrett的食道有关，这是一种预防疾病，目前的指南建议内窥镜筛查和监测。这导致了越来越多的早期腺癌被诊断为内镜下可治愈的。尽管手术切除和化学放疗可有效消除癌症，但这些治疗的发病率很大。早期癌症的内窥镜治疗包括内窥镜粘膜切除和光动力疗法。内窥镜粘膜切除可以去除含有组织的癌症，并允许对肿瘤深度和程度进行准确的组织学确定。但是，粘膜切除通常不会去除所有前粘膜，并且残留的非癌性巴雷特粘膜发生癌症复发的发生率很高。我们的假设是内窥镜疗法可以治疗早期食管腺癌。该研究的主要目的是确定除内窥镜粘膜切除以增加早期腺癌患者的无癌症生存外，是否还需要光动力疗法。该研究将涉及一百例早期食管腺癌患者，可以通过粘膜切除完全去除。切除癌症后，这些患者将被随机分配以接受光动力疗法或仔细观察。这项研究的次要目的是确定预测癌症进展的生物标志物是否包括非整倍性，使用新型细胞学技术进行的p53或p16的杂合性丧失可以与在组织上进行的流式细胞仪相关。这项研究的第三个目的是确定这些已知的生物标志物是否可以用于识别患有肿瘤的患者，并受益于其他疗法。除了这些已知的生物标志物外，还将从这些患者中存储组织，以确定其他生物标志物是否可能在定义适当的治疗组中有用。这项研究的第四个目的是确定这些治疗后患者的生活质量，因为这是选择内窥镜治疗的重要原因。将每季度进行一般性和疾病与健康相关的生活质量评估，以确定其在治疗之前，期间和之后的健康状况。需要实现这些特定目标，以帮助设计未来的试验，以确定早期食管腺癌治疗的最佳策略。在这项研究中开发的诊断和治疗技术可以应用于其他胃肠道肿瘤。