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KNBP based MRD monitoring of resectable stage II-IV colorectal cancer and its correlation with prognosis

KNBP based MRD monitoring of resectable stage II-IV colorectal cancer and its correlation with prognosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065302
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Case series:None

Sponsors

Cancer Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with colorectal cancer who have been diagnosed for the first time or who have survived without tumor for more than 5 years and recurred; 2. Preoperative biopsy revealed adenocarcinoma, including classic and special types; 3. II - IV colorectal cancer that can be operated according to the evaluation of the investigator; 4. MSS type II patients with high risk factors can be operated. High risk factors include: T4, poor tissue blood differentiation (3/4 grade), vascular invasion, nerve invasion, preoperative intestinal obstruction or tumor site perforation, positive or unknown cutting edge, insufficient safe distance of cutting edge, and less than 12 lymph nodes; 5. All operable patients (pT1-4N+M0), including but not limited to patients with locally advanced rectal cancer who need preoperative radiotherapy and chemotherapy (CRT) or whole course neoadjuvant therapy (TNT); 6. Operative stage IV patients, including but not limited to patients with liver metastasis; 7. The results of gene detection of tumor tissue after surgery showed that any gene of KRAS/NRAS/BRAF/PIK3CA had a driving mutation (subject to the molecular diagnosis report of the hospital pathology department); 8. Patients who cooperate in collecting blood samples before operation can meet the requirements of gene detection; 9. Aged >= 18 years, male or female; 10. ECOG PS: 0-1; 11. Subjects volunteered to participate in the study and signed an informed consent form before the operation, with good compliance and regular blood sample acquisition.

Exclusion criteria

Exclusion criteria: 1. Complicated with other malignant tumors within 5 years; 2. Non primary colorectal cancer; 3. MSI-H stage II colorectal cancer; 4. Patients evaluated as pCR after preoperative conversion therapy or neoadjuvant chemotherapy; 5. Stage ? patients with multiple systemic metastases; 6. Unable to obtain enough tissue and blood samples for molecular detection; 7. According to the judgment of the researcher, the subject has other factors that may lead to the forced termination of the study.

Design outcomes

Primary

MeasureTime frame
ctDNA;

Countries

China

Contacts

Public ContactSun Yanlai

Affiliated Cancer Institute of Shandong First Medical University

sunyanlai@126.com+86 13075398196

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026