Monitoring blood markers to predict colorectal cancer recurrence after surgery
A Prospective Multicentre Clinical Study of Dynamic Monitoring of Plasma ctDNA Methylation Markers to Predict Recurrence of Colorectal Cancer After Complete Resection of Peritoneal Metastases
This study is testing if blood markers can help predict if colorectal cancer will come back after surgery in patients who have had their cancer completely removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06903325 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the role of postoperative plasma ctDNA methylation markers in predicting the recurrence of colorectal cancer in patients who have undergone complete resection of peritoneal metastases. It involves collecting blood samples from participants to analyze ctDNA methylation status and correlating these findings with clinical outcomes over a follow-up period of at least 24 months. The study aims to enhance understanding of how these biomarkers can inform recurrence-free survival rates in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with colorectal adenocarcinoma who have undergone R0/R1 resection and have peritoneal metastasis.
Not a fit: Patients with other primary malignancies, severe comorbidities, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting cancer recurrence, allowing for timely interventions and improved patient outcomes.
How similar studies have performed: While the specific approach of using ctDNA methylation markers is relatively novel, similar studies have shown promise in using ctDNA for monitoring cancer recurrence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -1. No gender limit, age greater than 18 years old; 2, ECOG score ≤1; 3. Life expectancy ≥2 years; 4. Colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma confirmed by histopathology; 5, preoperative PCI score ≤20, peritoneal tumor cytoreductive surgery (CRS), surgery to achieve R0/1 resection; 6. Be able to understand the situation of this study and sign the informed consent. 7\. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary). Exclusion Criteria: * 1\. Combined with primary malignant tumors of other organs (current or within the past 5 years) (excluding patients with skin basal cell carcinoma and cervical carcinoma in situ undergoing radical treatment); 2. Severe mental illness or drug abuse; 3, severe heart, lung, vascular disease can not tolerate surgery; 4. Pregnant or lactating women.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Guoxiang Cai — Fudan University
- Study coordinator: Guoxiang Cai, MD, PhD
- Email: hanlingyu_ann@sina.cn
- Phone: +86-18819431363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.