NCT05536089

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Sep 2022Dec 2028

Study Start

First participant enrolled

September 5, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

6 years

First QC Date

September 7, 2022

Last Update Submit

May 21, 2024

Conditions

Cancer Colorectal

Keywords

early detection

Outcome Measures

Primary Outcomes (2)

  • 5y DFS

    The 5-year disease free survival rate of the patients from both cohorts.

    5 years

  • ctDNA methylation markers versus CT/MRI

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

    5 years

Secondary Outcomes (1)

  • 3y DFS

    3 years

Study Arms (2)

ctDNA positive

Postoperative ctDNA positive

Diagnostic Test: a multi-locus blood-based assay

ctDNA negative

Postoperative ctDNA negative

Diagnostic Test: a multi-locus blood-based assay

Interventions

a multi-locus blood-based assayDIAGNOSTIC_TEST

Colorectal tumor-specific plasma ctDNA methylation markers detection

ctDNA negativectDNA positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related 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 Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available.

    PMID: 34487783RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • KeFeng Ding, Ph.D

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY DIRECTOR

  • Rui Liu, Ph.D

    Singlera Genomics Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HongFeng cao, Ph.D

CONTACT

13957117804hongfengcao@zju.edu.cn

Rui Liu, Ph.D

CONTACT

rliu@singleragenomics.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 10, 2022

Study Start

September 5, 2022

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)