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

NCT03416478 | Unknown

• 1 other identifier: FFJC2017-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Cancer; ctDNA; Surveillance

Keywords

Colorectal Cancer; ctDNA; Surveillance

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  Two years

Secondary Outcomes (1)

• Overall survival

  Two years

Study Arms (1)

ctDNA test group

Diagnostic Test: ctDNA test

Interventions

ctDNA test DIAGNOSTIC_TEST

ctDNA test to find some possible mutation.

ctDNA test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yet-sen University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Xiaojian Wu, MD, PhD

  Sixth Affiliated Hospital, Sun Yet-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojian Wu, MD, PhD

CONTACT

86-020-38455325; wuxjian@mail.sysu.edu.cn

Yufeng Chen, MD, PhD

CONTACT

86-020-38455325; chenyf78@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

CN (1)