Early-Onset Colorectal Cancer Versus Late-Onset Colorectal Cancer: a Prospective Observational Cohort Study to Explore the Clinical, Sociodemographic, Genetic, and Molecular Characteristics Associated With Adverse Oncological Outcomes (
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Incidence rate ratio of colorectal cancer recurrence
研究概览
简要总结
This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients
详细描述
Early Onset Colorectal Cancer (EOCRC), defined as a Colorectal Cancer (CRC) arising before the age of 50, is increasing and displays more aggressive features compared with Late Onset Colorectal Cancer (LOCRC, with a diagnosis after the age of 50). EOCRC patients have indeed a higher incidence rate of CRC recurrence after surgery compared with LOCRC, even at early CRC stages (stage I or II). The reasons underlying the more aggressive patterns are almost unknown but may span and can be represented by a combination of socioeconomic factors (including low economic income and access to screening programs, diagnosis, or therapy), behavioral and lifestyle factors (including diet, sedentary behaviors, or increased stress and anxiety), and molecular or genetic factors.
The aim of this study is to prospectively validate our previous retrospective findings, demonstrating a higher incidence rate of CRC recurrence in early stage EOCRC, and explore the possible association between lifestyle, dietary, socioeconomics, molecular and genetic factors and postoperative CRC survival.
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 aged more than 18 years old at the time of inclusion.
- •Patients with a proven diagnosis of colorectal adenocarcinoma, as reported by the staging histological biopsies.
- •Patients with a preoperative staging I-III.
- •Patients scheduled for elective curative colorectal resection.
- •Patients with rectal cancer who underwent neoadjuvant therapy can be included in the study.
- •Patients able and willing to comply with the protocol requirements (samples' collection and questionnaires' compilation).
排除标准
- •Patients with metastatic disease at diagnosis.
- •Patients requiring an emergent procedure.
- •Patients undergoing palliative surgery (for example, fecal diversion).
- •Patients with a surgical indication for benign lesions (for example, adenoma or dysplasia).
- •Patients with an intraoperative finding of a lesion other than adenocarcinoma will be withdrawn from the study.
- •Patients with an intraoperative finding of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
- •Patients with a concomitant diagnosis of Inflammatory Bowel Disease.
- •Patients with a known genetic syndrome (for example, Lynch syndrome or Familial Adenomatous Polyposis).
结局指标
主要结局
Incidence rate ratio of colorectal cancer recurrence
时间窗: 24 months after surgery
Incidence rate ratio of 24-month colorectal cancer recurrence- defined as any radiological or endoscopic evidence of local recurrence or distal metastasis after the index surgery in stage I-III patients- between the study cohorts
次要结局
- Correlation between genetic profile and incidence rate of colorectal cancer recurrence(24 months after surgery)
- Correlation between molecular profile and incidence rate of colorectal cancer recurrence(24 months after surgery)
- Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence(24 months after surgery)
- Correlation between lifestyle and incidence rate of colorectal cancer recurrence(24 months after surgery)