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

Fujian Provincial Cancer Hospital

Status: Unknown

Conditions: Colorectal Cancer Stage III; Colorectal Cancer Stage II

Treatments: Procedure: Chemotherapy time

Study type: Interventional

Funder types: Other

Identifiers

NCT05131243

FZ-CON-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ctDNA positive patients

Experimental group

Description:

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.

Treatment:

Procedure: Chemotherapy time

Procedure: Chemotherapy time

ctDNA negative patients

Active Comparator group

Description:

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.

Treatment:

Procedure: Chemotherapy time

Procedure: Chemotherapy time