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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Colorectal Cancer ctDNA Surveillance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ctDNA test group

ctDNA test

Intervention Type DIAGNOSTIC_TEST

ctDNA test to find some possible mutation.

Interventions

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ctDNA test

ctDNA test to find some possible mutation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No