Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Correlation of ctDNA clearance with activity of chemotherapy
研究概览
简要总结
This clinical trial collects biospecimen samples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis. Deoxyribonucleic acid, or DNA, is the material that carries all the information about how a living thing will work and function. Everyone is born with the same DNA in all our cells throughout our body. Sometimes, some of the cells in the body develop abnormalities in the DNA that cause those cells to grow abnormally and uncontrollably. Cancer occurs when there is abnormal and uncontrolled growth of cells. The DNA in cancer cells is therefore different from the DNA someone is born with. The Signatera ctDNA assay is a laboratory test that takes tumor (cancer) tissue and evaluates it for unique tumor DNA. This evaluation is used to create a report (otherwise known as an assay) personalized to each person's cancer. The personalized assay creates a personalized blood test to detect the level of abnormal DNA from the cancer that may be circulating in the body. Once this personalized blood assay is designed, it may be used to monitor a person's blood for the presence of ctDNA, which will indicate the presence or absence of cancer over time, even after treatment.
详细描述
This study is an exploratory analysis of the utility of ctDNA as a sensitive biomarker in patients with Peritoneal Carcinomatosis treated with chemotherapy, CRS and/or hyperthermic intraperitoneal chemotherapy (HIPEC).
OBJECTIVES:
I. To measure changes in circulating tumor deoxyribonucleic acid (ctDNA) in patients with peritoneal carcinomatosis (PC) from gastrointestinal (GI) cancers who are candidates for cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC).
II. To determine the percentage of patients on protocol with undetectable ctDNA (clearance rate) after complete CRS.
III. To identify any associations between clinical staging of CRS and measurable ctDNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with histologically confirmed carcinoma of presumed gastrointestinal origin (gastric, esophageal, colorectal, appendiceal, hepatobiliary or peritoneal carcinomatosis of apparent GI primary) with documented diffuse peritoneal carcinomatosis, either by conventional imaging studies, positive ascitic fluid analysis, or surgical staging
- •Measurable or evaluable disease by cross-sectional imaging studies
- •Patients must be candidates for possible surgical cytoreduction (with or without HIPEC) as determined by a study surgical oncologist
- •Age >= 18 years
- •Estimated life expectancy of at least 12 months
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Patients must sign informed consent
- •Be willing to present for medical exams, blood draws and imaging as scheduled in protocol
- •Be able to donate two 10 mL tubes of blood every 3 months
- •Women of childbearing potential will undergo routine screening evaluation for pregnancy prior to enrollment and be managed per standard of care
排除标准
- •Patients without a confirmed pathologic diagnosis of carcinoma
- •Second uncontrolled primary malignancy
- •Patients who are pregnant
- •Patients who cannot undergo a therapeutic surgical cytoreduction
- •Bone marrow transplant or other organ transplant recipient
- •Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
- •Patients with cardiovascular or pulmonary risk factors contributing to high risk for surgical complications, at the discretion of the surgeon
- •Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
研究组 & 干预措施
Diagnostic (biospecimen collection)
Patients will receive standard treatment with surgery, HIPEC, and chemotherapy as appropriate to the patient situation, extent of disease and multi-disciplinary evaluation.
Patients undergo blood sample collection for ctDNA analysis at baseline, pre-surgery, post-surgery and every 3 months up to 2 years.
Patients undergo tissue collection before or during surgery and their medical records are reviewed.
干预措施: Biospecimen Collection - blood and tissue sample collection (Procedure)
Diagnostic (biospecimen collection)
Patients will receive standard treatment with surgery, HIPEC, and chemotherapy as appropriate to the patient situation, extent of disease and multi-disciplinary evaluation.
Patients undergo blood sample collection for ctDNA analysis at baseline, pre-surgery, post-surgery and every 3 months up to 2 years.
Patients undergo tissue collection before or during surgery and their medical records are reviewed.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Correlation of ctDNA clearance with activity of chemotherapy
时间窗: Baseline, pre-surgery, 3-4 weekd post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Will correlate ctDNA clearance with activity of chemotherapy in this disease pre-op and post-op
Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS)
时间窗: Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Will compare results with clinical staging of CRS (surgical staging, surgical outcomes, Peritoneal Carcinoma Index \[PCI\] and cytoreduction \[CC\] score). ctDNA clearance rate defined as the % of patients on our protocol with undetectable ctDNA. Will associate ctDNA changes with clinical response by Response Evaluation Criteria in Solid Tumors and surgical staging, surgical outcomes, PCI and CC score using standard T-testing, log-rank analysis or similar non-parametric testing.
次要结局
- Associations between CEA levels and ctDNA levels(Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS))
- Associations between CA19.9 levels and ctDNA levels(Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS))
- ctDNA and its association with results of next generation sequence (NSG) analysis from original tumor tissue.(Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS))
- Positivity rate of ctDNA in patients with peritoneal carcinomatosis(Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS))
- Associations between CA125 levels and ctDNA levels(Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS))
研究者
Henry Richard Alexander, MD
Chief Surgical Officer, Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey