Using ctDNA to improve diagnosis and treatment for colorectal cancer spread to the abdomen

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

This study is testing if checking for tumor DNA in the blood can help doctors better diagnose and treat colorectal cancer that has spread to the abdomen.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04752930 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of circulating tumor DNA (ctDNA) to assist in the diagnosis, early intervention, and prognosis of peritoneal metastases in colorectal cancer patients. It is a prospective, open-label, randomized controlled trial that monitors the mutational profile of ctDNA using next-generation sequencing (NGS). The study aims to establish a correlation between postoperative ctDNA status and patient outcomes, focusing on those at high risk for peritoneal metastasis. Participants will be closely monitored for ctDNA levels and undergo imaging assessments to evaluate their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have undergone radical surgery for colorectal cancer and have high-risk factors for peritoneal metastasis.

Not a fit: Patients with no evidence of colorectal cancer or those who have not undergone standard adjuvant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier diagnosis and more effective treatment strategies for patients with colorectal cancer and peritoneal metastases.

How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer progression, suggesting this approach may be beneficial but still requires further validation.

Eligibility criteria

Inclusion Criteria:

* 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);
* 6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month;
* Patients who have finished standard adjuvant therapy after surgery; (Choose 5-FU or 5-FU analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)；
* Patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ;
* Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study.

Exclusion Criteria:

* 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;
* Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases;
* Patients who cannot be followed up as scheduled;
* Patients who participated in other clinical studies within 3 months prior to the trial;
* Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.

Where this trial is running

Guangzhou, Guangdong

• Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Hui Wang, MD, PhD

Conditions Colorectal Cancer; Peritoneal Metastases; ctDNA