MRD Test in Common Risk Stage II Colorectal Cancer

Not yet recruiting

• Conditions: Stage II Colorectal Cancer

• Registration Number: NCT05795010
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

Patients with colorectal cancer who were confirmed as stage II general risk type in the postoperative pathological report began to be enrolled. Observe the sensitivity of the detection of micro-MRD before operation and the postoperative positive rate of this type of patients.

Detailed Description

This observation part is about the patients with general risk stage II colorectal cancer who have received R0 resection after screening by nanofiltration criteria. Twenty milliliters of venous blood samples were reserved before surgery, and tumor tissue samples were reserved within 30 minutes in vitro during surgery. After the pathological diagnosis of the patients after surgery, they began to be enrolled. To observe the sensitivity of MRD detection in preoperative diagnosis of patients with general risk stage II colorectal cancer, and to study its positive rate one month and three months after operation.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study Start: 2023-03-30
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03
• Primary Completion: 2023-04-10
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18-75;
• Pathologically confirmed rectal adenocarcinoma;
• Pathological differentiation is highly or moderately differentiated;
• The pathological stage was pT3N0, that is, invasion of the proper muscular layer of the intestinal wall without lymph node metastasis;
• No new adjuvant treatment before operation
• There was no vascular infiltration and nerve infiltration in postoperative pathology;
• No preoperative intestinal obstruction or tumor site perforation;
• No postoperative pathological margin was positive or unknown;
• The distance between the pathological cutting edge and the tumor was more than 1 cm;
• Invasion of mesentery of intestinal wall ≤ 2mm;
• More than 12 lymph nodes were submitted for examination;
• Nonlocal recurrence and distant metastasis;
• No multiple primary carcinoma of colon and rectum;
• Physical condition score PS ≤ 2 points;
• Patients and their families can understand and are willing to participate in this study and provide written informed consent.

Exclusion Criteria

• Multiple intestinal carcinomatosis
• Previous history of malignant tumor,
• There are concurrent malignant tumors in the whole body except for colorectal cancer
• Colorectal cancer with preoperative anti-tumor treatment
• Pregnant or lactating women
• There are serious complications during or after operation, affecting the prognosis
• Hepatitis B or Hepatitis C antibody positive
• HIV antibody positive
• Other diseases considered by the research doctor to affect the prognosis and survival
• Other conditions that the research doctor believes are not consistent with this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive rate of preoperative MRD test	six months	To observe the positive rate of preoperative MRD detection for stage II colorectal cancer

Secondary Outcome Measures

Name	Time	Method
Positive rate of MRD test 1 month and 3 months after operation	nine months	Observe the positive rate of MRD detection at 1 month and 3 months after operation for stage II colorectal cancer

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China