Status:
UNKNOWN
ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Colorectal Cancer
Peritoneal Metastases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 24 2025
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04752930
Start Date
August 24 2020
End Date
August 24 2025
Last Update
February 12 2021
Active Locations (1)
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1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655