GUIDING MULTI-MODAL THERAPIES AGAINST MINIMAL RESIDUAL DISEASE BY LIQUID BIOPSIES
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recurrence of pancreatic cancer
研究概览
简要总结
The overall objective of this study is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.
Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.
Specifically, we want to determine the association between disease-free survival (DFS) and ctDNA detection status after (1) curative-intended surgery and (2) adjuvant chemotherapy.
详细描述
The study will prospectively enroll patients who undergo potentially curative surgery for PDAC. The intervention is repeated blood sampling at pre-defined time points.
Patient identification Patients with PDAC are screened for eligibility by the involved physicians based on the protocol of the multidisciplinary tumor board (MDT). The screening will be done based on the electronic health record in the electronic journal (at present, for example, Take Care). The National Health Record may be accessed for some patients to complete the record.
Patient recruitment and informed consent The involved physicians screen patients meeting the inclusion criteria specified below. Eligible patients are approached in person or initially by phone, after they have been informed about the diagnosis and the planned surgery. Patients are given written and oral information about the project by a trained research nurse or by an involved physician. Informed consent will be obtained before the beginning of any study-related procedures.
The signed and dated consent forms are scanned into the project's electronic database and stored physically in a locked space.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
- •Age 18 years or older.
- •Patient able to understand and sign written informed consent in Swedish.
- •Scheduled for curative intent surgical resection.
排除标准
- •Hereditary pancreatic cancer.
- •Verified distant metastases.
- •Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study.
- •Other cancers (excluding prior pancreatic cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
结局指标
主要结局
Recurrence of pancreatic cancer
时间窗: 1 month - 24 months after surgical resection of the tumor
Occurence of a "positive" biomarker or markers after adjuvant chemotherapy prior to clinically overt recurrence.
次要结局
- Effect of standard-of-care (SOC) chemotherapy on biomarker(s)(1 month - 24 months after surgical resection of the tumor)
研究者
Matthias Löhr
Professor of Gastroenterology & Hepatology
Karolinska University Hospital