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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03416478
• Other study ID #: FFJC2017-01
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2018
• Last updated: January 30, 2018
• Start date: January 2018
• Est. completion date: December 2020

Study information

• Verified date: January 2018
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiaojian Wu, MD, PhD
• Phone: 86-020-38455325
• Email: wuxjian[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• ctDNA
• Recurrence
• Surveillance

Intervention

Diagnostic Test:
• ctDNA test
ctDNA test to find some possible mutation.

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital, Sun Yet-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival		Two years
Secondary	Overall survival		Two years