Accurate Allocation of Completion Resection in Early Colorectal Cancer: an Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 18
- 主要终点
- ctDNA analysis
研究概览
简要总结
After introducing a nationwide screening program for colorectal cancer (CRC) in Denmark, more cases of early-stage CRC are being detected. Cancers in the earliest stages are often removed locally, either during the diagnostic colonoscopy or through planned minimally invasive surgery.
This early detection of cancer, and thereby an improved prognosis, is a positive feature but has also introduced a new clinical dilemma. Is the patient fully cured by the local resection, or do they need further surgery? Whether further surgery is recommended at the Multi-Disciplinary Team (MDT) board meeting depends on the outcome of specific criteria from the histopathological assessment of the locally removed specimen.
The presence of these criteria does not, however, translate directly into the presence of residual disease - merely into a theoretically increased risk. In Denmark, after surgery, the fraction of cases with residual disease has been around 15% for many years. In the remaining 85% of cases, local removal alone was curative - and the surgery appears excessive.
Investigating blood samples for the presence of circulating tumor DNA (ctDNA) is a new and promising method for cancer detection. The method utilizes that cancer cells release ctDNA into the circulation. ctDNA detected in blood drawn from a patient a few days after local removal of a tumor indicates that residual disease is present and further treatment, such as surgery, is needed.
The purpose of this study is to investigate, whether analyses of ctDNA can correctly identify patients with residual disease after local removal of early CRC. If this identification proves accurate, many patients can be spared further surgery.
详细描述
KEY POINTS
- 85% of patients receiving completion bowel resection after local removal of pT1 CRC are overtreated.
- ctDNA is a biomarker of residual cancer disease and could help identify those patients, where completion bowel resection is necessary, sparing those that are already cured.
GOALS ● To explore ctDNA analysis for identification of the patient subgroup with residual disease after local excision of pT1 tumors and hence need for completion resection.
PERSPECTIVES
● Practice-changing evidence for ctDNA-guided risk-stratification for pT1 CRCs after local excision, an important and well-recognized clinical dilemma in the management of CRC.
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
- •Patients having undergone local resection of pT1 colorectal cancer and with planned completion resection, as recommended by the local MDT board
- •The reason for the planning of completion resection may be non-micro radical tumor removal, piece-meal resection making assessment of resection margin impossible or the presence of one or more histological risk factors
排除标准
- •Patients not able to understand information about the study and/or give informed consent
- •Patients not accepting blood samples stored in biobank
- •Cases with non-obtainable primary tumor tissue, required for the conduction of mutational analyses
- •Other recent (within 5 years) or current malignant disease, except basocellular carcinoma of the skin
- •Planned completion resection due to other factors, such as patient's wish or hereditary disposition for CRC, and with the absence of risk factors mentioned above
- •Withdrawal of consent
结局指标
主要结局
ctDNA analysis
时间窗: After recruitment of the last patient, we expect that ctDNA analyses can be performed within 6 months
Blood samples will be categorized as either ctDNA positive or negative
次要结局
- Pathological evaluation of the resected specimen from the completion resection(After recruitment of the last patient, these data will be available (expected in spring 2024))
- 30- and 90-day mortality related to the completion resection(These data will be extracted from the patient's medical records 3 months after surgery)
- Postoperative morbidities(After recruitment of the last patient, these data will be extracted from the patient's medical records within 6 months)