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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05536089
Other study ID # Recovery-C
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 5, 2022
Est. completion date December 2028

Study information

Verified date May 2024
Source Singlera Genomics Inc.
Contact HongFeng cao, Ph.D
Phone 13957117804
Email hongfengcao@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2028
Est. primary completion date September 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
a multi-locus blood-based assay
Colorectal tumor-specific plasma ctDNA methylation markers detection

Locations

Country Name City State
China Second Affiliated Hospital Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Singlera Genomics Inc. Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumo — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 5y DFS The 5-year disease free survival rate of the patients from both cohorts. 5 years
Primary ctDNA methylation markers versus CT/MRI ctDNA methylation predictors of outcome will be compared to CT/MRI 5 years
Secondary 3y DFS The 3-year disease free survival rate of the patients from both cohorts. 3 years
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