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Trial Title:
ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation
NCT ID:
NCT05536089
Condition:
Cancer Colorectal
Conditions: Official terms:
Recurrence
Conditions: Keywords:
early detection
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
a multi-locus blood-based assay
Description:
Colorectal tumor-specific plasma ctDNA methylation markers detection
Arm group label:
ctDNA negative
Arm group label:
ctDNA positive
Summary:
In this study, the investigators aimed to apply their previously developed multi-locus
blood-based assay targeting circulating tumor DNA methylation to monitor postoperative
relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II
(without high risk) colorectal cancer after radical resection.
Detailed description:
This is a prospective, multicenter, observational, real-world study. Research objects:
patients with surgically resectable colorectal cancer and ctDNA positive before surgery
in stage I and stage II (without high risk). After giving fully informed consent, the
participants will undergo the regular treatment according to NCCN guidelines. Serial
analysis of ctDNA will be performed at specific time points including pre-treatment,
postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and
every 6 months for the rest 3 years). Participants will be observed and examined during
the follow-up period.
Criteria for eligibility:
Study pop:
Patients 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. The written informed
consent must be obtained from the patient prior to enrollment. The following criteria
apply to all patients enrolled onto the study unless otherwise specified.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients must have histologically confirmed stage I/II (without high risk)
colorectal cancer.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients need to receive surgical resection, and with ctDNA positive prior to
resection of colorectal cancer (CRC).
- Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology
Group (ECOG) Performance Scale.
- 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:
- Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract
cancer.
- Induction of neoadjuvant systemic therapy prior to resection of CRC.
- Patient is pregnant or lactating.
- 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.
- Inadequate tumor material (either quality and quantity) to support circulating tumor
DNA (ctDNA) analysis.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
HongFeng Cao, Ph.D
Phone:
13957117804
Email:
hongfengcao@zju.edu.cn
Start date:
September 5, 2022
Completion date:
December 2028
Lead sponsor:
Agency:
Singlera Genomics Inc.
Agency class:
Industry
Collaborator:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Singlera Genomics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05536089
