Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

ctDNA monitoring will be performed at protocol-specified intervals and requirement

Imaging examination will be performed at protocol-specified intervals and requirement

Patients who undergoing radical surgery for colorectal cancer for 6\~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled, and diagnostic laparoscopy will be performed immediately after enrollment. Patients with positive peritoneal metastasis (PCI score \<20) will be treated with CRS+HIPEC. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months in patients with negative peritoneal metastasis. Laparoscopy will be performed when imaging suggested peritoneal metastasis (oligometastases). Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.

ctDNA monitoring

Patients who undergoing radical surgery for colorectal cancer for 6\~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled. and there will be no need to conduct endoscopic exploration immediately after enrollment. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months until imaging suggested peritoneal metastasis (oligometastases). Patients with positive peritoneal metastasis (PCI score \<20) will be treated with CRS+HIPEC. Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.

Imageology

Hui Wang, MD, PhD

Tenghui Ma, MD, PhD

This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.

ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer

Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study

The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.

DR of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.

DR of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

DR of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

Will be compared in both arms.

PPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.

PPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

PPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

Will be compared in both arms.

NPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.

NPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

NPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

Will be compared in both arms.

This scale measures the extent of peritoneal cancer throughout the peritoneal cavity.

The range of this scale is from 0 to 39.

0 = no disease within the peritoneal cavity

0-9 = minimal disease

10-29 = moderate disease

30-39 = extensive disease

Lower values are considered a better outcome for the patient.

Will be compared in both arms.

The degree to which the disease was able to be excised during the procedure.

This scale ranges from CC0-CC3.

CC0 = all disease has been cleared, with no visible peritoneal carcinomatosis after CRS

CC1 = microscopic disease remains (Nodules persisting \< 2.5 mm after CRS)

CC2 = macroscopic disease remains (Nodules persisting between 2.5 mm and 2.5 cm)

CC3 = Substantial Macroscopic disease remains (Nodules persisting \> 2.5 cm)

Lower values are considered a better outcome, with CC0/1 classed as favourable and CC2/3 indicating an incomplete clearance of disease.

Will be compared in both arms.

Whether the patient is still alive and free of disease or not.

Will be compared in both arms.

Whether the patient is still alive or not.

Will be compared in both arms.

Spots Global Cancer Trial Database for ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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