Dynamic Monitoring of ctDNA Methylation to Predict Relapse in Colorectal Cancer After Radical Resection (POSTCA)

NCT03737539 | Unknown DMC

• 1 other identifier: FDCRC42-CGX (POSTCA trial)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of patients with resectable colorectal cancer was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers (Multigene methylation detection). Dynamic monitoring of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with colorectal cancer after radical resection of tumor, 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.

Conditions

Colorectal Cancer; Circulating Tumor DNA; Surveillance; Methylation

Keywords

Colorectal Cancer; Circulating tumor DNA; Surveillance; ctDNA Methylation

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival (DFS)

  The primary endpoint for this study is Disease Free Survival (DFS), which will be assessed using RECIST version 1.1.

  2-year DFS

• ctDNA methylation markers versus CT/MRI

  ctDNA methylation predictors of outcome will be compared to CT/MRI

  2 years

Study Arms (1)

Colorectal cancer

Patients diagnosed with resectable colorectal cancer

Diagnostic Test: Multigene methylation detection

Interventions

Multigene methylation detection DIAGNOSTIC_TEST

Colorectal tumor-specific plasma ctDNA methylation markers detection

Colorectal cancer

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 resectable 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.

You may qualify if:

• Male or female ≥ 18 years of age on the day of signing informed consent.
• Patients must have histologically confirmed 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Second Military Medical University: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator
• RenJi Hospital: collaborator
• Hebei Medical University Fourth Hospital: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, 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

Central Study Contacts

Guoxiang Cai, M.D. Ph.D.

CONTACT

+86 13611831623; gxcai@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

CN (1)