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

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).

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Surveillance; ctDNA
• Intervention / Treatment: Diagnostic test: ctDNA test

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • The Sixth Affiliated Hospital, Sun Yet-sen University
    • Contact: Xiaojian Wu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage II or stage III colorectal cancer must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ctDNA test group	Diagnostic test: ctDNA test; ctDNA test to find some possible mutation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease Free Survival	Two years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Two years

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Xiaojian Wu, MD, PhD, Sixth Affiliated Hospital, Sun Yet-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Surveillance; ctDNA
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence
• Other Study ID Numbers: FFJC2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No