ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

Cancer Colorectal Clinical Trial

Official title:

ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536089
• Other study ID #: Recovery-C
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cancer Colorectal
• Recurrence

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