Clinical trial NCT05131243: the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer Stage II
Colorectal Cancer Stage III
Keywords: ctDNA
Adjuvant chemotherapy
Colorectal Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ctDNA status
timeFrame: Two weeks
measure: ctDNA dynamic detection
timeFrame: 6 months
Secondary outcomes:
measure: Imaging examination
timeFrame: 6 months
measure: Tumor Marker examination
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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citation: Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.