Suspended

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

What is being tested

ctDNA monitoring

+ Imageology

Diagnostic Test

Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 75 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: August 2020

See protocol details

Summary

Principal SponsorSixth Affiliated Hospital, Sun Yat-sen University

Study ContactHui Wang, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 24, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleCirculating 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

NCT04752930

Principal SponsorSixth Affiliated Hospital, Sun Yat-sen University

Study ContactHui Wang, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

138 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

8 inclusion criteria required to participate

Patients must be a man or woman of at 18-75;

Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21；

Patients with primary colorectal cancer proven by pathology；

Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage);

Show More Criteria

8 exclusion criteria prevent from participating

Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer;

ASA class Ⅳ to Ⅴ;

Patients who have other existence of distant metastasis outside the abdomen;

Patients with serious mental illness;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, ChinaOpen Sixth Affiliated Hospital, Sun Yat-sen University in Google Maps

SuspendedOne Study Center