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

Study Overview
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Brief Summary
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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
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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.

Official Title
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the Role of ctDNA in Predicting the Recurrence Risk of Stage Ⅱ and Ⅲ Colorectal Cancer and the Dynamic Changes in ctDNA of Patients With Adjuvant Chemotherapy

Conditions
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Colorectal Cancer Stage II, Colorectal Cancer Stage III

Intervention / Treatment
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* Procedure: Chemotherapy time
* Procedure: Chemotherapy time


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ctDNA positive patients<br>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. | Procedure: Chemotherapy time<br>* 6 months of chemotherapy<br>|
| Active Comparator: ctDNA negative patients<br>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. | Procedure: Chemotherapy time<br>* 3 months of chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ctDNA status | Detect postoperative tissue ctDNA status | Two weeks | 
| ctDNA dynamic detection | ctDNA dynamic monitoring during postoperative adjuvant chemotherapy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging examination | Imaging examination during postoperative adjuvant chemotherapy | 6 months | 
| Tumor Marker examination | Tumor marker examination during postoperative adjuvant chemotherapy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ctDNA, Adjuvant chemotherapy, Colorectal Cancer