Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416478
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University

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).

Condition or disease Intervention/treatment
Colorectal Cancer ctDNA Surveillance 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Implication of Plasma Circulating Tumor DNA (ctDNA) in the Recurrence Surveillance of Stage II and III Colorectal Cancer: a Prospective Study
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ctDNA test group Diagnostic Test: ctDNA test
ctDNA test to find some possible mutation.




Primary Outcome Measures :
  1. Disease Free Survival [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Two years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416478


Contacts
Layout table for location contacts
Contact: Xiaojian Wu, MD, PhD 86-020-38455325 wuxjian@mail.sysu.edu.cn
Contact: Yufeng Chen, MD, PhD 86-020-38455325 chenyf78@mail.sysu.edu.cn

Locations
Layout table for location information
China
the Sixth Affiliated Hospital, Sun Yet-sen University Recruiting
Guangzhou, China
Contact: Xiaojian Wu, MD, PhD         
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Xiaojian Wu, MD, PhD Sixth Affiliated Hospital, Sun Yet-sen University
Layout table for additonal information
Responsible Party: Xiaojian Wu, Vice President, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03416478    
Other Study ID Numbers: FFJC2017-01
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University:
Colorectal Cancer
ctDNA
Surveillance
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes