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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05131243
Enrollment
100
Registered
2021-11-23
Start date
2021-12-01
Completion date
2023-05-01
Last updated
2021-11-23

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

Conditions

Colorectal Cancer Stage II, Colorectal Cancer Stage III

Keywords

ctDNA, Adjuvant chemotherapy, Colorectal Cancer

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.

Interventions

PROCEDUREChemotherapy time

6 months of chemotherapy

Sponsors

Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ctDNA statusTwo weeksDetect postoperative tissue ctDNA status
ctDNA dynamic detection6 monthsctDNA dynamic monitoring during postoperative adjuvant chemotherapy

Secondary

MeasureTime frameDescription
Imaging examination6 monthsImaging examination during postoperative adjuvant chemotherapy
Tumor Marker examination6 monthsTumor marker examination during postoperative adjuvant chemotherapy

Contacts

Primary ContactXiaojie Wang
634793899@qq.com13509399900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026