ESTROGEN RECEPTOR TARGETED TREATMENT OF NON-MUSCLE INVASIVE BLADDER CANCER

非肌肉浸润性膀胱癌的雌激素受体靶向治疗

• 批准号: 8581543
• 负责人: Guilherme Godoy
• 金额: $ 14.3万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-15 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8581543
• 关键词: Advisory Committees; Aftercare; Animal Model; Apoptosis; Area; Biological Assay; Biometry; Biopsy; Bladder Neoplasm; Bladder Tissue; Blood; Cancer cell line; Cell Proliferation; Chemoprevention; Chemopreventive Agent; Cicatrix; Cleaved cell; Clinical; Clinical Trials; Clinical Trials Design; Common Terminology Criteria for Adverse Events; Data; Detection; Development; Doctor of Medicine; Doctor of Philosophy; Enrollment; Ensure; Environment; Estrogen Receptor beta; Estrogen Receptors; Ethics; Fibrosis; Freezing; Goals; Grant; Health; Histologic; Human; Immunohistochemistry; Induction of Apoptosis; Leadership; Lesion; Malignant neoplasm of urinary bladder; Measures; Medical center; Medicine; Mentors; Monitor; Muscle; National Cancer Institute; Necrosis; Normal tissue morphology; Oral; Outcome; Pharmaceutical Preparations; Prevention strategy; Procedures; Proliferation Marker; Protocols documentation; RNA Splicing; Recurrence; Research; Research Design; Research Personnel; Research Project Grants; Research Training; Resected; Risk; Role; Sampling; Scientist; Selective Estrogen Receptor Modulators; Solid; Staging; Staining method; Stains; Tamoxifen; Texas; Time; Tissues; Toxic effect; Training; Training Programs; Training Support; Treatment Efficacy; Tumor Markers; Tumor Tissue; Urine; Urologic Cancer; Urologic Oncology; Urology; Validation; Variant; Woman; Work; Writing; base; cancer recurrence; career; caspase-3; cell growth; college; cost; data acquisition; experience; follow-up; human tissue; improved; mRNA Expression; men; metabolomics; neoplastic cell; pre-clinical; prevent; professor; research study; response; standard care; survivin; treatment effect; tumor; tumor growth

DESCRIPTION (provided by applicant): Guilherme Godoy, M.D. is a Urologic Oncology fellow in the Scott Department of Urology at Baylor College of Medicine (BCM). His career has been research-oriented and his goal is to become an expert and independent investigator in the field of urological cancers, with specific focus in bladder cancer. The proposed research study includes the development of a new strategy for prevention and management of non-invasive bladder cancer using oral tamoxifen. This strategy has the potential for reduction in the cost and invasiveness of management and surveillance protocols. Dr. Godoy is enrolled in the Clinical Scientist Training Program at BCM, pursuing his Ph.D. degree in Clinical Investigation. He will receive extensive training in grant writing, research presentation, clinical trial design and management, biostatistics, and ethics in the conduct of research. BCM, as an integral part of the world-renowned Texas Medical Center, provides the ideal environment to support his training and research needs. Dr. Godoy is mentored by Seth P. Lerner, MD, FACS, Professor of Urology and Beth and Dave Swalm Chair in Urologic Oncology at the Scott Department of Urology, BCM. Dr. Lerner is a recognized leader in the field of bladder cancer, with a successful mentoring record and a solid experience in clinical trial leadership. Dr. Godoy is further supported by an advisory committee, comprising expert leaders in all areas of research related to his current project, ensuring excellence of his work. Dr. Godoy's research project is focused on investigating the role of tamoxifen in the chemoprevention of non- invasive bladder cancer recurrence. The hypotheses are that oral Tamoxifen treatment (1) is able to reduce the size or eliminate low/intermediate-risk non-muscle invasive bladder cancer tumors, and (2) show a positive correlation between the magnitude of the clinical response to the therapy with pretreatment expression levels of estrogen receptor (especially estrogen receptor ¿ and its splice variants) in the tumor and normal tissues. It is expected that (3) therapy will be well tolerated and also hypothesized that (4) response to treatment will be associated with changes in a previously identified bladder cancer metabolomic signature. The study of an oral drug in the treatment of non-invasive bladder cancer has the potential not only to improve oncological outcomes, but also to introduce a new paradigm in the management of bladder cancer.

描述（由适用提供）：M.D。Guilherme Godoy是Baylor医学院Scott泌尿外科（BCM）的泌尿外科肿瘤学研究员。他的职业生涯一直以研究为导向，他的目标是成为泌尿外科癌症领域的专家和独立研究者，并特别关注膀胱癌。拟议的研究包括使用口服他莫昔芬制定一种新的预防和管理非侵入性膀胱癌的策略。该策略有可能降低管理和监视协议的成本和侵入性。 Godoy博士正在BCM参加临床科学家培训计划，攻读博士学位。临床研究学位。他将接受广泛的研究培训，研究演示，临床试验设计和管理，生物统计学和伦理学的培训。 BCM是世界知名的德克萨斯医疗中心不可或缺的一部分，为支持他的培训和研究需求提供了理想的环境。 Godoy博士由BCM Scott泌尿外科泌尿外科教授Seth P. Lerner医学博士，FACS，FACS和FACS和Dave Swalm泌尿外科肿瘤学主席。 Lerner博士是膀胱癌领域的公认领导者，具有成功的心理记录，并且在临床试验领导力方面具有良好的经验。 Godoy博士得到了咨询委员会的进一步支持，在与他当前的项目有关的所有研究领域完成了专家领袖，从而确保了他的工作卓越。 Godoy博士的研究项目的重点是研究他莫昔芬在非侵入性膀胱癌复发的化学预防中的作用。 The hypotheses are that oral Tamoxifen treatment (1) is able to reduce the size or eliminate low/intermediate-risk non-muscle invasive bladeder cancer tumors, and (2) show a positive correlation between the magnitude of the clinical response to the therapy with pretreatment expression levels of estrogen receptor (especially estrogen receptor ¿ and its splice variants) in the tumor and normal tissues.预计（3）治疗将得到很好的耐受性，并且还假设（4）对治疗的反应将与先前确定的膀胱癌代谢组签名的变化有关。对非侵入性膀胱癌治疗的口服药物的研究不仅有可能改善肿瘤学结果，而且还可以引入新的囊肿管理范式。