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

NCT06903325 | Recruiting

• 1 other identifier: CRIP-ctDNA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis after R0/R1 resection. The main questions it aims to answer are: Preoperative and postoperative plasma ctDNA methylation detection (ColonAiQ) was performed in patients with peritoneal metastasis from colorectal cancer who underwent R0/R1 resection. Clinical information of patients was collected to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis. Participants will: The patients were followed up according to the normal review procedure of the hospital and the NCCN guidelines until at least 24 months after surgery. The review content included CT/MRI imaging evaluation and blood CEA (every 3 months). Whole-blood samples were obtained for timely plasma separation and ctDNA extraction at 1 month after surgery (before the start of postoperative chemotherapy) and every 3 months through 24 months after surgery. One blood sample was obtained when tumor recurrence was first detected on imaging. Detection of methylation in tissue and plasma samples

1. 1.GutSeer methylation NGS was performed on peritoneal metastatic cancer tissues and paired normal peritoneal tissues.
2. 2.ctDNA GutSeer methylation NGS was performed on plasma samples before surgery, 1 month after surgery, 24 months after surgery, and when tumor recurrence was first detected by imaging examination.
3. 3.ctDNA methylation PCR (ColonAiQ) was performed on plasma samples before surgery, 1 month after surgery, every 3 months to 24 months after surgery, and when tumor recurrence was first detected by imaging examination.

Conditions

Colorectal Cancer; Peritoneal Metastases

Outcome Measures

Primary Outcomes (1)

• predictive value of ColonAiQ postoperative recurrence free survival (RFS)

  explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.

  2023.10-2027.10

Secondary Outcomes (4)

• predictive value of GutSeer for RFS

  2023.10-2027.10

• predictive value of ctDNA for dynamic monitoring

  2023.10-2027.10

• difference of predictive value of ColonAiQ and GutSeer

  2023.10-2027.10

• the advance time of dynamic detection of plasma ctDNA methylation compared with imaging monitoring

  2023.10-2027.10

Study Arms (2)

POM1 positive

Patients whose 1-month-postoperative plasma ctDNA methylation status is positive

Other: As an observational study, we did not intervene

POM1 negative

Patients whose 1-month-postoperative plasma ctDNA methylation status is negative

Other: As an observational study, we did not intervene

Interventions

As an observational study, we did not intervene OTHER

Interventions

POM1 negative; POM1 positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peritoneal metastasis from colorectal cancer whose preoperative imaging PCI score was ≤20 and could be evaluated for R0/R1 resection were screened for enrollment. Preoperative plasma samples and tumor tissue samples were collected for ctDNA multigene methylation markers detection. Patients who achieved R0/R1 resection of peritoneal carcinomatosis were enrolled in this clinical study.

You may qualify if:

• 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.
• \. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Fudan University: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Guoxiang Cai

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoxiang Cai, MD, PhD

CONTACT

+86-18819431363; hanlingyu_ann@sina.cn

Lingyu Han, MD, PhD

CONTACT

+86-19521330776; lingyuhan24@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)