The Implication of ctDNA in the Recurrence Surveillance of Stage II and III Colorectal Cancer

• Conditions: Surveillance; Colorectal Cancer; ctDNA
• Interventions: Diagnostic Test: ctDNA test

• Registration Number: NCT03416478
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant method for tumor recurrence in stage II and III colorectal cancer (CRC).

Detailed Description

This study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of a short-term disease recurrence in surgical resective stage II and stage III colorectal cancer (CRC). The investigators will recruit newly diagnosed CRC patients, systematically collect their blood samples at the following time point: before surgery, one week after surgery, every three months for the first year and every six months for the second year, which are coincidence with the recommended clinical follow-up. Patients' outcome and survival will be tracked. These study will permit assessment of ctDNA as a predictive and surveillant method for a short-term (two years) tumor recurrence in comparison with other parameters.

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Last Update Submitted: 2018-01-30
• Study First Posted: 2018-01-31
• Last Update Posted: 2018-02-01
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male or female ≥ 18 years of age on the day of signing informed consent.
• Patients must have histologically confirmed stage II or IIIcolorectal cancer.
• Patients must receive radical resection.
• Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria

• Patient has severe anemia.
• Patients received neoadjuvant treatment.
• Patients received blood transfusion two weeks before or during the surgical resection.
• Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ctDNA test group	ctDNA test	-

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	Two years

Secondary Outcome Measures

Name	Time	Method
Overall survival	Two years

Trial Locations

Locations (1)

the Sixth Affiliated Hospital, Sun Yet-sen University; 🇨🇳 Guangzhou, China