NCT05558436

Brief Summary

This is a prospective diagnostic study. This study is to compare the performance between circulating tumor DNA (ctDNA) methylation and carcinoembryonic antigen (CEA) in detecting colorectal tumor. Firstly, based on the identification of differential ctDNA methylation biomarkers, the diagnostic model is established and the diagnostic performance was compared with that of CEA. Secondly, the stage stratification model was established preliminarily based on differential ctDNA methylation biomarkers and the performance was also compared with that of CEA.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
662

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

September 25, 2022

Last Update Submit

May 8, 2024

Conditions

Colorectal Tumor

Keywords

colorectal canceradvanced adenomacirculating tumor DNA methylation

Outcome Measures

Primary Outcomes (1)

  • Diagnostic sensitivity

    The comparison of sensitivity between ctDNA methylation and CEA in detecting colorectal cancer

    3 years

Secondary Outcomes (1)

  • Stage stratification

    3 years

Study Arms (2)

Case group

Patients with colorectal cancer and advanced adenoma.

Diagnostic Test: Genome-wide methylation profiling

Control group

Healthy participants and patients with benign colorectal disease.

Diagnostic Test: Genome-wide methylation profiling

Interventions

Genome-wide methylation profilingDIAGNOSTIC_TEST

Detection for colorectal tumor-specific ctDNA methylation biomarkers

Case groupControl group

Eligibility Criteria

Age18 Years - 80 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.

You may qualify if:

  • Case group
  • Patients must have histologically confirmed colorectal cancer or advanced adenoma.
  • Patients need to receive surgical resection or endoscopic resection.
  • Patients have a performance status of ≤1 on the ECOG Performance Scale.
  • Written informed consent must be obtained.
  • Control group
  • Written informed consent must be obtained.
  • Individuals must receive colonoscopy.

You may not qualify if:

  • Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemoradiotherapy and targeted therapy.
  • Patients received antibiotics regularly.
  • Patients received blood transfusion two weeks before the drawn of blood sample.
  • Patients with indications of emergency surgery, including bleeding, obstruction and perforation.
  • Patients who are positive for Human Immunodeficiency Virus (HIV).
  • Patients with abnormal liver and kidney function.
  • Patients with the history of other malignancies, inflammatory bowel disease and Lynch syndrome.
  • Patients who are pregnant or breastfeeding.
  • Alcoholic or drug abusers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (12)

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

    PMID: 33433946BACKGROUND

  • Schilsky RL, Nass S, Le Beau MM, Benz EJ Jr. Progress in Cancer Research, Prevention, and Care. N Engl J Med. 2020 Sep 3;383(10):897-900. doi: 10.1056/NEJMp2007839. No abstract available.

    PMID: 32877579BACKGROUND

  • Adler A, Geiger S, Keil A, Bias H, Schatz P, deVos T, Dhein J, Zimmermann M, Tauber R, Wiedenmann B. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014 Oct 17;14:183. doi: 10.1186/1471-230X-14-183.

    PMID: 25326034BACKGROUND

  • Luo H, Zhao Q, Wei W, Zheng L, Yi S, Li G, Wang W, Sheng H, Pu H, Mo H, Zuo Z, Liu Z, Li C, Xie C, Zeng Z, Li W, Hao X, Liu Y, Cao S, Liu W, Gibson S, Zhang K, Xu G, Xu RH. Circulating tumor DNA methylation profiles enable early diagnosis, prognosis prediction, and screening for colorectal cancer. Sci Transl Med. 2020 Jan 1;12(524):eaax7533. doi: 10.1126/scitranslmed.aax7533.

    PMID: 31894106BACKGROUND

  • Grotowski M. [Antigens (CEA and CA 19-9) in diagnosis and prognosis colorectal cancer]. Pol Merkur Lekarski. 2002 Jan;12(67):77-80. Polish.

    PMID: 11957811BACKGROUND

  • Kanwal R, Gupta K, Gupta S. Cancer epigenetics: an introduction. Methods Mol Biol. 2015;1238:3-25. doi: 10.1007/978-1-4939-1804-1_1.

    PMID: 25421652BACKGROUND

  • Shen SY, Singhania R, Fehringer G, Chakravarthy A, Roehrl MHA, Chadwick D, Zuzarte PC, Borgida A, Wang TT, Li T, Kis O, Zhao Z, Spreafico A, Medina TDS, Wang Y, Roulois D, Ettayebi I, Chen Z, Chow S, Murphy T, Arruda A, O'Kane GM, Liu J, Mansour M, McPherson JD, O'Brien C, Leighl N, Bedard PL, Fleshner N, Liu G, Minden MD, Gallinger S, Goldenberg A, Pugh TJ, Hoffman MM, Bratman SV, Hung RJ, De Carvalho DD. Sensitive tumour detection and classification using plasma cell-free DNA methylomes. Nature. 2018 Nov;563(7732):579-583. doi: 10.1038/s41586-018-0703-0. Epub 2018 Nov 14.

    PMID: 30429608BACKGROUND

  • Xu RH, Wei W, Krawczyk M, Wang W, Luo H, Flagg K, Yi S, Shi W, Quan Q, Li K, Zheng L, Zhang H, Caughey BA, Zhao Q, Hou J, Zhang R, Xu Y, Cai H, Li G, Hou R, Zhong Z, Lin D, Fu X, Zhu J, Duan Y, Yu M, Ying B, Zhang W, Wang J, Zhang E, Zhang C, Li O, Guo R, Carter H, Zhu JK, Hao X, Zhang K. Circulating tumour DNA methylation markers for diagnosis and prognosis of hepatocellular carcinoma. Nat Mater. 2017 Nov;16(11):1155-1161. doi: 10.1038/nmat4997. Epub 2017 Oct 9.

    PMID: 29035356BACKGROUND

  • Xie H, Mahoney DW, Foote PH, Burger KN, Doering KA, Taylor WR, Then SS, Cao X, McGlinch M, Berger CK, Wu TT, Hubbard JM, Allawi HT, Kaiser MW, Lidgard GP, Ahlquist DA, Kisiel JB. Novel Methylated DNA Markers in the Surveillance of Colorectal Cancer Recurrence. Clin Cancer Res. 2021 Jan 1;27(1):141-149. doi: 10.1158/1078-0432.CCR-20-2589. Epub 2020 Oct 7.

    PMID: 33028593BACKGROUND

  • 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: 34487783BACKGROUND

  • Liang N, Li B, Jia Z, Wang C, Wu P, Zheng T, Wang Y, Qiu F, Wu Y, Su J, Xu J, Xu F, Chu H, Fang S, Yang X, Wu C, Cao Z, Cao L, Bing Z, Liu H, Li L, Huang C, Qin Y, Cui Y, Han-Zhang H, Xiang J, Liu H, Guo X, Li S, Zhao H, Zhang Z. Ultrasensitive detection of circulating tumour DNA via deep methylation sequencing aided by machine learning. Nat Biomed Eng. 2021 Jun;5(6):586-599. doi: 10.1038/s41551-021-00746-5. Epub 2021 Jun 15.

    PMID: 34131323BACKGROUND

  • Ji H, Xu M, Hu Y, Yan B, Wu W, Zheng J, Yan J. Preoperative Identification of Lymph Node Metastasis in Colorectal Cancer Using Noninvasive ctDNA Methylation Signatures: Results from a Prospective Study. Dis Colon Rectum. 2025 Dec 11. doi: 10.1097/DCR.0000000000004089. Online ahead of print.

    PMID: 41378988DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fresh plasma and tumor tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jun Yan, M.D., Ph.D.

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2022

First Posted

September 28, 2022

Study Start

June 1, 2022

Primary Completion

May 1, 2024

Study Completion

December 31, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

CN(1)