Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases

NCT06404593 | Completed

• 1 other identifier: PKUCRLM-1
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.

Conditions

Liver Metastases; Colorectal Cancer; Surgery; Circulating Tumor DNA; Minimal Residual Disease

Keywords

Minimal Residual Disease; Colorectal Liver Metastases

Outcome Measures

Primary Outcomes (2)

• progression-free survival

  1 year

• overall survival

  5 year

Study Arms (5)

Group 1

Blood sampling 7 days after surgery

Diagnostic Test: Blood sampling

Group 2

Blood sampling 1 month after surgery

Diagnostic Test: Blood sampling

Group 3

Blood sampling 3 to 6 months after surgery

Diagnostic Test: Blood sampling

Group 4

Blood sampling 6 to 9 months after surgery

Diagnostic Test: Blood sampling

Group 5

Blood sampling 9 to 12 months after surgery

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.

Group 1; Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study enrolled patients with colorectal liver metastases undergoing radical resection at Hepatopancreatobiliary Surgery Department I of Peking University Cancer Hospital.

You may qualify if:

• Before implementing any trial-related procedures, written informed consent should be signed;
• \>=20 and \<= 85 years old, male or female;
• Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma;
• According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging;
• The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases;
• The general physical condition is good (ECOG score 0-1);
• Life expectancy of more than 3 months;
• There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery;
• adequate organ function;
• samples meet NGS quality control requirements;
• The subjects are able and willing to comply with the visits, treatment plans, laboratory tests and other research-related procedures stipulated in the research protocol.

You may not qualify if:

• Patients who are intolerant to systemic chemotherapy or surgery;
• Patients with multiple primary lesions;
• Blood samples and/or baseline tissue samples that do not meet the requirements for testing (hemolysis, low tumor cell content, insufficient DNA extraction yield, etc.);
• Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements
• Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up
• Not all metastatic lesions were resected after conversion therapy, or liver metastatic lesions did not achieve R0 resection
• No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm, Residual

Interventions

Blood Specimen Collection

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: June 18, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CN (1)