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

The Implication of Plasma Circulating Tumor DNA (ctDNA) in the Recurrence Surveillance of Stage II and III Colorectal Cancer: a Prospective Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03416478

Enrollment

Registered

2018-01-31

Start date

2018-01-31

Completion date

2020-12-31

Last updated

2018-02-01

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

Conditions

Colorectal Cancer, ctDNA, Surveillance

Keywords

Colorectal Cancer, ctDNA, Surveillance

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.

Interventions

DIAGNOSTIC_TESTctDNA test

ctDNA test to find some possible mutation.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disease Free Survival	Two years

Secondary

Measure	Time frame
Overall survival	Two years

Countries

China

Contacts

Primary ContactXiaojian Wu, MD, PhD

wuxjian@mail.sysu.edu.cn86-020-38455325

Backup ContactYufeng Chen, MD, PhD

chenyf78@mail.sysu.edu.cn86-020-38455325

Outcome results

None listed

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