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Status unknownNCT03416478Updated Feb 1, 2018

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

An observational study in Colorectal Cancer, ctDNA and Surveillance, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • ctDNA
  • Surveillance

Keywords

  • Colorectal Cancer
  • ctDNA
  • Surveillance
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • ctDNA test group

    Diagnostic Test: ctDNA test

Interventions

  • Diagnostic testctDNA test

    ctDNA test to find some possible mutation.

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What researchers measure

Primary outcomes

  1. Disease Free Survival

    Time frame: Two years

Secondary outcomes

  1. Overall survival

    Time frame: Two years

06

Study locations

1 of 1 sites recruiting
  • the Sixth Affiliated Hospital, Sun Yet-sen University
    Guangzhou, China
    • Xiaojian Wu, MD, PhD · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03416478
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
Xiaojian Wu (Vice President, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Jan 31, 2018
Start date
Jan 2018 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Feb 1, 2018

Study contacts

Xiaojian Wu, MD, PhD
Contact
wuxjian@mail.sysu.edu.cn
86-020-38455325
Yufeng Chen, MD, PhD
Contact
chenyf78@mail.sysu.edu.cn
86-020-38455325
Xiaojian Wu, MD, PhD
principal investigator · Sixth Affiliated Hospital, Sun Yet-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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