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

January 30, 2018 updated by: Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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