Generation of Patient Derived Pancreatic Cancer Cell Lines to Determine Mechanisms of Chemoresistance
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls
研究概览
简要总结
This pilot research trial studies patient derived cancer cell lines in identifying molecular changes in patients with previously untreated pancreatic cancer and are receiving gemcitabine hydrochloride-based chemotherapy. Cell lines refer to samples taken from the patient's tumor to grow for many months or years in a laboratory, and can therefore be studied scientifically. Studying cell lines in the laboratory may help doctors understand the genetic changes that occur to the tumor during chemotherapy that allows the tumor to resist or grow despite treatment.
详细描述
PRIMARY OBJECTIVES:
I. Compare the genetic profile of the tumor after progression has occurred, to the tumor prior to treatment.
SECONDARY OBJECTIVES:
I. Additional molecular patterns, beyond genetics, will be analyzed, including ribonucleic acid (RNA) and protein expression.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed pancreatic adenocarcinoma, any stage
- •>18 years of age
- •No prior systemic chemotherapy for pancreatic cancer, or currently undergoing first-line treatment for pancreatic cancer, or completed only first-line treatment for pancreatic cancer
- •A plan to undergo gemcitabine-based chemotherapy at Thomas Jefferson or a collaborating institution
- •Abdominal/pelvic CT scan or MRI within 4 months of the study
- •Signed study-specific informed consent
排除标准
- •Prior systemic chemotherapy for pancreatic cancer
- •Gender/Minority/Pediatric Inclusion for Research
结局指标
主要结局
Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls
时间窗: Up to 5 years
This method includes a preprocessing step to filter out unreliable reads, a statistical classification step to identify point mutations that differ from both the reference genome hg19 and the control sample at controlled false-positive rate, and a post-processing step to eliminate platform-specific artifacts inherent in next generation sequencing. ANNOVAR software will then be used to analyze candidate point mutations for their predicted impact on protein function, which will be used to select and prioritize specific mutations for validation and/or further study.
Identification of germline mutations in known cancer genes from whole blood genomic deoxyribonucleic acid, and somatic mutations in conditionally reprogrammed cells derived from pre-treatment and post-treatment (e.g., resistant) tumors
时间窗: Up to 5 years
The study will be considered a positive study if in any of the patients' samples, unique mutations are identified in the post-treatment derived cell lines that are not present in the pre-treatment derived cell lines from the same patient.
次要结局
未报告次要终点