The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Analysis of miRNA profile
研究概览
简要总结
Aberrant miRNA production has been linked to a wide range of human cancers and shown to play important roles in their genesis and growth. These miRNA can be detected in the blood and tumors of patients with cancer. The investigators hypothesize that the detection of certain miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA detection in PC patients will yield prognostic information and help predict the response to treatment.
详细描述
Specific aims of the study include:
- To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline before treatment and monthly throughout treatment.
- To analyze the miRNA profiles present at each time point.
- To determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
- To determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- 是
入选标准
- •Have biopsy proven adenocarcinoma of the pancreas
- •Have initially inoperable disease, classified as either locally advanced or metastatic disease
- •Recurrent disease after a Whipple procedure is allowed
- •Patients who are able to undergo resection after neoadjuvant therapy will continue to be followed after resection
- •Have radiographically measurable disease
- •Have an ECOG performance status of 2 or less
- •Be willing to contribute the required information and specimens
- •Provide written signed consent to participate
排除标准
- •Having received prior anti-cancer treatments for metastatic pancreatic cancer
- •Concurrently receiving systemic therapy for another cancer except androgen deprivation therapy for stable/controlled prostate cancer
- •Presence of other active cancer except for: adequately treated local basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of trial. Other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for > 5 years is allowable
研究组 & 干预措施
New Unresectable Pancreatic Cancer
Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease
干预措施: Blood draw (Procedure)
Control
Healthy individuals without cancer diagnoses to provide reference microRNA
干预措施: Blood draw (Procedure)
结局指标
主要结局
Analysis of miRNA profile
时间窗: Through study completion, up to 5 years
Analyze the miRNA profiles present at each time point.
次要结局
- miRNA PCR expression(Through study completion, up to 5 years)
- PCR miRNA validation(Through study completion, up to 5 years)
研究者
Richard Frank
Director of Cancer Research
Nuvance Health