Patients and designs
tumor, CRS, CRC
PRIMARY TUMOR, TUMOR, PATHOLOGY, BLIND
This was a prospectively, open-label, blind, and diagnostic study. Patients with CRC were recruited from the Sixth Affiliated Hospital of Sun Yat-sen University, China. All enrolled patients underwent surgical resection of primary tumor or conduct CRS procedure. CRC and PM were diagnosed by pathology. Peritoneal lavage fluids were collected at the start of surgery. After surgery, CRC patients with PM were enrolled in the experimental PM arm, while CRC patients without PM were included in the controlled non-PM arm. cfDNA experimental personnel and statisticians were blinded to the diagnosis of PM, while clinicians know the diagnosis. For stage IV cases, metastatic lesions such as liver or lung sites were preoperatively radically resected, or treated by radiofrequency ablation. Extensive PM with PCI > 20 was defined as late PM, which is not appropriate for CRS plus HIPEC according to previous studies [In the training cohort, the diagnostic power of peritoneal cfDNA by ultradeep NGS was investigated. A validation cohort was enrolled to verify the results. All enrolled patients were consented for the collection of peritoneal lavages, tumor tissue, blood and medical records under the protocols approved by local ethical institutional review board (IRB), which was in accordance with the Declaration of Helsinki and later amendments. Written informed consents were obtained from all enrolled patients. All authors reviewed and approved the final manuscript. The follow-up was conducted until at least one year after surgery by professional personnel.