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

Sun Yat-sen University

Status: Enrolling

Conditions: Peritoneal Metastases; Colorectal Cancer

Treatments: Diagnostic Test: ctDNA monitoring; Diagnostic Test: Imageology

Study type: Interventional

Funder types: Other

Identifiers

NCT04752930

SixthSunYetSen-ctDNA

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

138 participants in 2 patient groups

ctDNA monitoring

Experimental group

Description:

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

Treatment:

Diagnostic Test: ctDNA monitoring

Imageology (SOC)

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Imageology