Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer: a Population-based Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Develop a predictive model of the probability of receiving surgical treatment
研究概览
简要总结
The implementation of population screening programs for colorectal cancer (CRC) has led to a considerable increase in the prevalence T1 CRC originating on polyps amenable by endoscopy. The benefits of secondary oncological surgery in terms of disease free survival are not well established.
Hypothesis: The characteristics of the individuals and the polyp (endoscopic, histological) should allow us to discriminate T1 CRCs that may benefit from secondary surgery from those that only require local treatment. With the current criteria, the management of patients with T1 CRC is suboptimal since a high proportion of patients are refered for unnecessary surgeries without a clear benefit in terms of survival. Molecular signatures can help to discriminate those patients with good prognosis that do not require secondary surgery nor cancer related follow up.
详细描述
The primary objective of the study is to compare the effect of oncological surgery versus local treatment for the management of polyps with T1 CRC in relation to disease-free survival and morbi-mortality of the therapeutic procedure. We will also validate molecular signatures in endoscopic samples for the prediction of lymph node metastasis and survival. Methodology: Clinical Study: Retrospective population-based cohort study that will include baseline clinical and follow up data of more than 1400 T1 CRCs in at least 10 Spanish autonomous communities from 2007 to 2017. A centralized pathological review will be carried out by a group of expert pathologists. Inter and intraobserver variability for histological staging will be assessed. A predictive model will be created to discriminate individuals with high probability of receiving surgical and local treatment. For those patients who have a similar probability range, the results in progression-free survival and adverse events will be compared. Translational phase: A 5miRNAs and 8mRNA signature predictive of lymph node metastasis will be assessed in 200 endoscopic samples and related with prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with pT1 CRC will be included, regardless of endoscopic features, treatment received and lymph node staging
排除标准
- •CRC with other histology than adenocarcinoma
- •Patients with hereditary syndromes of CRC (Lynch syndrome, classical familial adenomatous polyposis) or inflammatory bowel disease.
- •Synchronous CRC
- •Metachronous CRC in the previous 5 years
- •Patients with metastatic neoplastic disease at the time of diagnosis
结局指标
主要结局
Develop a predictive model of the probability of receiving surgical treatment
时间窗: 1 year
Determine factors associated with the choice of primary treatment and final treatment (endoscopic, primary surgery or secondary surgery) and to develop a predictive model that allow discriminate individuals with high probability of receiving surgical treatment
Disease free survival
时间窗: 1 year
Evaluate the effect of surgery and local (endoscopic) treatment on disease free survival (expressed in months)
Validation of molecular signatures
时间窗: 2 years
Evaluate the validity of molecular signatures based on mRNA and miRNA (determined in endoscopic samples) for prediction lymph node metastasis
Overall survival
时间窗: 1 year
Evaluate the effect of surgery and local (endoscopic) treatment on overall survival (expressed in months)
次要结局
- Proportion of adverse events(1 year)
- Risk of lymph node metastasis(1 year)
- Prognosis(1 year)
- T1 CRC in screening program(1 year)
- Concordance of histological evaluation(2 years)
- Sensitivity and specificity of follow-up tests(1 year)
研究者
María Pellisé
Principal Investigator. Attending physician Gastroenterology department.
Hospital Clinic of Barcelona