Objective: Colorectal cancer (CRC) is the third most commonly diagnosed cancer in males and the second in females worldwide. Surgery is the leading therapy, followed by adjuvant chemotherapy, yet the presence of undetected micrometastatic tumor cells at the time of surgery in advanced CRC patients, contributes to the failure of treatment, resulting in relapse and metastatic diseases.
Recently, molecular detection of circulating tumor cell free DNA (ccfDNA) has been investigated as a potential prognostic marker. If its effectiveness were to be established, it could have a major role in addressing patients to a targeted treatment and to monitor the disease progression over time.
The aim of the study is to describe changes in the presence of circulating cell free DNA (ccfDNA) in patients with resectable colon cancer who have received immediate perioperative chemotherapy right after the surgical resection, 2 weeks and 4 weeks later. The levels of ccfDNA will be compared to those of patients who will start adjuvant chemotherapy after a standard interval of time (4-6 weeks).
Methods: The study is a prospective case-control pilot study to test ccfDNA in two cohorts, one receiving perioperative chemotherapy and a control cohort.
Patients with invasive colonic adenocarcinoma will be selected and a blood sample to test ccfDNA will be taken preoperatively, on postoperative day 14 and 30 days after the resection to evaluate changes deriving from the different treatment received.
Moreover, the level on ccfDNA will be analyzed 6 weeks after surgery, to monitor variations, especially in those patients who did not receive perioperative chemotherapy; also, it will be used to evaluate relapses or metastatic spread in the long term.
