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Predictive Value of Circulating Tumor DNA (ctDNA) for no Evidence of Disease (NED) Status in Metastatic Colorectal Cancer (mCRC) and Its Utility in Guiding Therapeutic Intervention: an Open-label, Prospective, Phase II Cohort Study
The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are: 1. Whether ctDNA monitoring could evaluate NED status ahead of normal radiologic monitoring. What about the concordance of evaluating NED status by ctDNA monitoring compared with normal radiologic monitoring? 2. Whether the patients with ctDNA positive status could benefit from early therapeutic intervention. Patients who receive any kinds of therapies with the aim of NED and are confirmed by clinical and radiologic examination will go through longitudinal ctDNA monitoring. According to the results of ctDNA monitoring, the patients will be divided into ctDNA positive group and ctDNA negative group. Patients in ctDNA positive group will receive individual therapeutic plan decided by the investigator. Patients in ctDNA negative group will receive regular examinations. When radiologic recurrences are confirmed, the patients will be re-evaluated for a second opportunity of radical resection.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Start Date
June 24, 2022
Primary Completion Date
December 24, 2023
Completion Date
December 24, 2025
Last Updated
December 2, 2022
110
ESTIMATED participants
ctDNA and adjuvant therapy
OTHER
ctDNA
OTHER
Lead Sponsor
Fudan University
Collaborators
NCT04657068
NCT06625775
Data Source & Attribution
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