Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dynamic Monitoring of ctDNA Methylation to Predict Relapse in Stage II-III Colorectal Cancer After Radical Resection

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: NCT03737539
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
Second Military Medical University
Shanghai University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Guoxiang Cai, Fudan University

Tracking Information
First Submitted Date November 8, 2018
First Posted Date November 9, 2018
Last Update Posted Date November 9, 2018
Actual Study Start Date September 1, 2018
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2018)
  • Disease Free Survival (DFS) [ Time Frame: 2-year DFS ]
    The primary endpoint for this study is Disease Free Survival (DFS), which will be assessed using RECIST version 1.1.
  • ctDNA methylation markers versus CT/MRI [ Time Frame: 2 years ]
    ctDNA methylation predictors of outcome will be compared to CT/MRI
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dynamic Monitoring of ctDNA Methylation to Predict Relapse in Stage II-III Colorectal Cancer After Radical Resection
Official Title Dynamic Monitoring of Circulating Tumor DNA Methylation to Predict Relapse in Stage II-III Colorectal Cancer After Radical Resection: A Prospective, Multicenter, Clinical Study
Brief Summary This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of patients with stage II-III colorectal cancer was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation). The methylation marker had a sensitivity of 93% in colorectal cancer patients with a specificity of 99% in healthy individuals. Dynamic monitoring of high-throughput next-generation sequencing of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with colorectal cancer after radical resection of stage II-III colorectal cancer, to explore the predictive effect of postoperative plasma ctDNA methylation on postoperative recurrence and whether dynamic monitoring of postoperative ctDNA methylation could be earlier than imaging examination to indicate tumor recurrence.
Detailed Description At present, the main treatment of stage II-III CRC (CRC) is surgical resection. CRC patients after radical surgery have good overall survival. However, there are still a large number of patients with postoperative recurrence. The postoperative recurrence rate of stage II CRC patients is 20-30%, and that of stage III CRC patients is 50-60%. Currently, there is no effective measures to predict whether patients suffer postoperative relapse. Patients can only periodically visit doctors in the hope of timely treatment in case of recurrence. Current clinical monitoring methods mainly include imaging detection and tumor markers detection. However, long-term monitoring may affect patients' quality of life and increase patients' economic burden. Therefore, biomarkers that can predict the prognosis of patients and screen out those who need intensive follow up are urgently warranted. At present, imaging is the mainly used approach to monitor tumor recurrence. Quantitative determination of ctDNA methylation in plasma may find tumor recurrence trend before imaging detection, indicating that quantitative determination of ctDNA methylation in plasma is a more sensitive monitoring approach than traditional imaging detection. Can next-generation sequencing of the plasma ctDNA methylation be a new recurrence monitoring technique and prognostic prediction method of stage II-III CRC in clinical practice? In this study, we aimed to monitor the dynamic level of plasma ctDNA methylation after surgery in patients with stage II-III CRC, and to explore the advantages of plasma ctDNA methylation detection over traditional CRC in recurrence monitoring and prognosis prediction. This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of patients with stage II-III CRC was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation). The methylation marker had a sensitivity of 93% in CRC patients with a specificity of 99% in healthy individuals. Dynamic monitoring of high-throughput next-generation sequencing of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with CRC after radical resection of stage II-III CRC, to explore the predictive effect of postoperative plasma ctDNA methylation on postoperative recurrence and whether dynamic monitoring of postoperative ctDNA methylation could be earlier than imaging examination to indicate tumor recurrence.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.
Condition
  • Colorectal Cancer
  • Circulating Tumor DNA
  • Surveillance
  • Methylation
Intervention Diagnostic Test: Next-generation sequencing (NGS)
NGS test for colorectal tumor-specific plasma ctDNA methylation markers
Study Groups/Cohorts
  • Stage II colorectal cancer
    Patients diagnosed with stage II colorectal cancer
    Intervention: Diagnostic Test: Next-generation sequencing (NGS)
  • Stage III colorectal cancer
    Patients diagnosed with stage III colorectal cancer
    Intervention: Diagnostic Test: Next-generation sequencing (NGS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 8, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female ≥ 18 years of age on the day of signing informed consent.
  • Patients must have histologically confirmed stage II/III colorectal cancer.
  • Patients need to receive surgical resection.
  • Patients must have a performance status of ≤1 on the ECOG Performance Scale.
  • Life expectancy of more than 5 years.
  • 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:

  • Patients received adjuvant treatment prior to the surgical resection.
  • Patients received blood transfusion two weeks before or during the surgical resection.
  • Patients with unresected advanced colorectal adenoma.
  • Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
  • Patients who are pregnant.
  • Patients who are alcoholic or drug abusers.
  • Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Guoxiang Cai, M.D. Ph.D. +86 13611831623 gxcai@fudan.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03737539
Other Study ID Numbers FDCRC42-CGX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Guoxiang Cai, Fudan University
Study Sponsor Fudan University
Collaborators
  • Second Military Medical University
  • Shanghai University of Traditional Chinese Medicine
Investigators Not Provided
PRS Account Fudan University
Verification Date November 2018