Danish Assessment of Minimal Residual Disease by Liquid Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 10
- 主要终点
- The prognostic value of ctDNA status
研究概览
简要总结
Approximately two-thirds of all colorectal cancer patients undergo surgery with the aim of curing them. However, despite the surgery, 20-25% of them experience relapse. It is possible to reduce the risk of relapse with chemotherapy, but as chemotherapy is associated with significant side effects, it is only given to patients at high risk of relapse. Currently, the risk is assessed based on an examination of the removed tumor tissue.
In a previous research project, blood samples were taken after patients' surgery and examined for the presence of circulating tumor DNA (ctDNA). When cancer cells in solid tumors die, they release DNA, which can be detected in the blood. DNA in the blood has a half-life of less than 2 hours, so if ctDNA is found in a blood sample taken, e.g., 14 days after surgery, the patient most likely still has cancer cells in their body.
The results show that if a patient has ctDNA in their blood after surgery, the risk of relapse is high. The presence of ctDNA in the blood has the potential to be a better indicator of the risk of future relapse than the tumor examination used today. Therefore, ctDNA analysis has the potential to become a marker that will be used in the future clinical setting for monitoring colorectal cancer.
The overall objective of this study is to confirm that ctDNA found in a blood sample after intended curative treatment for CRC is a marker of residual disease and risk of recurrence and is applicable in clinical practice.
详细描述
Colorectal cancer (CRC) is the third most common cancer worldwide. Approximately 75% of patients initially present with potentially curable disease, but despite curatively intended treatment up to 25 % of them experience a relapse of the disease. Upon diagnosis, survival of CRC can be improved by offering adjuvant chemotherapy to patients with a high risk of recurrence, or by early detection of recurrence enabling early intervention which improves patient survival significantly. To achieve this, it is essential to have sensitive and specific tools for correctly identifying patients with a high risk of recurrence and the need for adjuvant therapy, and for early detection of recurrence facilitating early intervention. Non-invasive analysis of circulating tumor DNA (ctDNA) is an emerging tool that has this potential.
Objectives
The overall objective of the study is to confirm that ctDNA detected after intended curative treatment for CRC is a marker of residual disease and risk of recurrence and is applicable in clinical practice.
Primary objectives
P1: To determine the prognostic value of a patient's ctDNA status and compare it with other known prognostic factors. Specifically, the aim is to determine the association between 3-year disease-free survival (DFS) and ctDNA detection status immediately after 1) curative-intended surgery and 2) adjuvant chemotherapy.
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
- •DANISH.MRD part I - Surgery
- •Inclusion Criteria:
- •Colon or rectal cancer, clinical tumor stage I-III.
- •Patient able to understand and sign written informed consent.
- •Scheduled for curative-intent resectional surgery (including "compromised" curative resections).
排除标准
- •Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
- •Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- •Verified distant metastases.
- •Malignant colorectal polyps diagnosed after polypectomy.
- •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.
- •DANISH.MRD part II - Surveillance
- •Inclusion Criteria:
- •Participation in DANISH.MRD part I - Surgery.
- •Colorectal cancer, UICC stage III.
- •Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime).
- •Exclusion Criteria:
- •Not treated with adjuvant chemotherapy
- •Treated with neoadjuvant chemo-radiation therapy.
- •Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma).
- •Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
- •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.
结局指标
主要结局
The prognostic value of ctDNA status
时间窗: 3 years after surgery
Especially, the association between 3-year disease-free survival and ctDNA status after surgery and after adjuvant chemotherapy
次要结局
- Ranking of commercial ctDNA diagnostics(3 years after surgery)
- Lead time between molecular and clinical recurrence(3 years after surgery)
- Prognostic power of ctDNA at the time point of an indeterminate CT scan(3 years after surgery)
- Change in ctDNA levels after adjuvant chemotherapy(3 years after surgery)
- Correlation between ctDNA analysis and findings on CT scans(3 years after surgery)
- Molecular characterization(3 years after surgery)