the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer

Not Applicable

• Conditions: Colorectal Cancer Stage III; Colorectal Cancer Stage II
• Interventions: Procedure: Chemotherapy time

• Registration Number: NCT05131243
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

The purpose of this study was to observe the relationship between ctDNA as a molecular marker of colorectal cancer and the risk of postoperative recurrence.

Detailed Description

In this clinical study, ctDNA will be detected in postoperative patients with stage Ⅱ and Ⅲ colorectal cancer to evaluate the correlation between ctDNA and the risk of postoperative recurrence. According to the dynamic changes of ctDNA after adjuvant chemotherapy, the correlation between ctDNA and postoperative DFS will be compared, and the feasibility of ctDNA as a molecular marker to evaluate the risk of postoperative recurrence of colorectal cancer will be investigated.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Last Update Submitted: 2021-11-11
• Study First Posted: 2021-11-23
• Last Update Posted: 2021-11-23
• Study Start: 2021-12-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1. Patients with colorectal cancer diagnosed pathologically as stage Ⅱ and stage Ⅲ.
• 2. The patient underwent radical surgical treatment.
• 3. The patient has the results of genetic genetic testing for gastrointestinal tumors, including the genetic mutation status of MMR genes and related genes (MLH1, MSH2, MSH6, PMS2, MLH3, EPCAM).
• 4. The patient understands and is willing to sign a written informed consent document.
• 5. During the treatment process, the patient can cooperate to provide samples of each node.
• 6. The patient can provide corresponding clinical materials, including but not limited to case diagnosis, imaging evaluation, and serum protein marker test results.

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Exclusion Criteria

• 1. The patient cannot provide a complete and qualified specimen.
• 2. The patient has other primary malignant tumors or serious medical illnesses.
• 3. The patient cannot cooperate with the follow-up.
• 4. Conditions that other researchers deemed inappropriate for continuing to participate in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ctDNA positive patients	Chemotherapy time	Postoperative ctDNA-positive patients will receive chemotherapy for 6 months.The ctDNA dynamic detection and imaging examination will be completed every 3 months, and tumor markers will be detected in each chemotherapy cycle.
ctDNA negative patients	Chemotherapy time	Postoperative ctDNA-negative patients will receive chemotherapy for 3 months. The ctDNA dynamic detection and imaging examination will be completed every 3 months, and tumor markers will be detected in each chemotherapy cycle.

Primary Outcome Measures

Name	Time	Method
ctDNA status	Two weeks	Detect postoperative tissue ctDNA status
ctDNA dynamic detection	6 months	ctDNA dynamic monitoring during postoperative adjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
Tumor Marker examination	6 months	Tumor marker examination during postoperative adjuvant chemotherapy
Imaging examination	6 months	Imaging examination during postoperative adjuvant chemotherapy