Colorectal TumorNCT05558436

Comparison of Diagnostic Sensitivity Between ctDNA Methylation and CEA in Colorectal Cancer

An observational study of Colorectal Tumor, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Colorectal Tumor
What is being tested?: Genome-wide methylation profiling
How many people: 662 participants
Where: 1 siteChina
Study dates: 1 Jun 2022to 31 Dec 2024
How long will I take part?: 4 Weeks
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

Patients with the history of other malignancies, inflammatory bowel disease and Lynch syndrome.
Patients who are pregnant or breastfeeding.
Alcoholic or drug abusers.

Trial locations and contacts

1 site in 1 country.

China1 site

Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Comparison of Diagnostic Sensitivity Between Circulating Tumor DNA Methylation and Carcinoembryonic Antigen in Colorectal Cancer

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.

Read the detailed description

Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer. It is reported that patients prefer non-invasive methods rather than invasive methods for the detection of CRC. Carcinoembryonic antigen (CEA) is commonly employed in clinical practice for early detection of CRC, but it is limited for its low sensitivity, which is around 30%-40%. DNA methylation is a commonly used biomarker for non-invasive tumor detection in plasma. We aim to develop and validate a ctDNA methylation-based blood test for CRC diagnosis based on genome-wide methylation detection. There are two steps in the study. Firstly, this prospective study aims to identify colorectal tumor differential circulating tumor DNA (ctDNA) methylation biomarkers, establish the diagnostic model. Secondly, we performed a preliminary study to stratify early-stage and advanced-stage disease based on the differential biomarkers.

Conditions: Colorectal Tumor
Being tested: Genome-wide methylation profiling
Keywords: colorectal cancer, advanced adenoma, circulating tumor DNA methylation
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Genome-wide methylation profilingDiagnostic test
Detection for colorectal tumor-specific ctDNA methylation biomarkers

Study groups in NCT05558436
Study group	Role	What they receive
Case group		Patients with colorectal cancer and advanced adenoma. Receives: Diagnostic Test: Genome-wide methylation profiling
Control group		Healthy participants and patients with benign colorectal disease. Receives: Diagnostic Test: Genome-wide methylation profiling

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic sensitivity
The comparison of sensitivity between ctDNA methylation and CEA in detecting colorectal cancer
Measured: 3 years

Secondary outcomes (1)

Stage stratification
The performance of the novel model to stratify early-stage and advanced-stage disease, and comparing with that of CEA.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202231 Dec 2024

First posted28 Sep 2022
Study start1 Jun 2022
Primary completion1 May 2024
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Colorectal TumorStudies of the same condition, open and under way.
More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 662 participants (actual)
Target duration: 4 Weeks

IDs, dates and publications

ClinicalTrials.gov ID: NCT05558436
Sponsor's protocol ID: NFEC-2022-245
Status last verified: May 2024
First submitted: 25 Sep 2022
Last updated: 10 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Undecided

Publications

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.
PubMed 33433946
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.
PubMed 32877579
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.
PubMed 25326034
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.
PubMed 31894106
Grotowski M. [Antigens (CEA and CA 19-9) in diagnosis and prognosis colorectal cancer]. Pol Merkur Lekarski. 2002 Jan;12(67):77-80. Polish.
PubMed 11957811
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.
PubMed 25421652
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.
PubMed 30429608
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.
PubMed 29035356
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.
PubMed 33028593
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.
PubMed 34487783
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.
PubMed 34131323
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 Circulating Tumor DNA Methylation Signatures: Results From a Prospective Study. Dis Colon Rectum. 2026 Apr 1;69(4):586-597. doi: 10.1097/DCR.0000000000004089. Epub 2025 Dec 11.
PubMed 41378988

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Diagnostic Sensitivity Between Circulating Tumor DNA Methylation and Carcinoembryonic Antigen in Colorectal Cancer
ClinicalTrials.gov ID: NCT05558436
Acronym / sponsor ID: NFEC-2022-245
Conditions: Colorectal Tumor
Keywords: colorectal cancer, advanced adenoma, circulating tumor DNA methylation
Study type: Observational
Recruitment status: Unknown status
Enrolment: 662 participants (actual)
Lead sponsor: Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
Study start: 1 Jun 2022 (actual)
Primary completion: 1 May 2024 (actual)
Study completion: 31 Dec 2024 (estimated)
First posted: 28 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 4 Weeks
Number of arms: 2

Arm	Type	Receives
Case group	–	Diagnostic Test: Genome-wide methylation profilingPatients with colorectal cancer and advanced adenoma.
Control group	–	Diagnostic Test: Genome-wide methylation profilingHealthy participants and patients with benign colorectal disease.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (9 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Genome-wide methylation profilingDetection for colorectal tumor-specific ctDNA methylation biomarkers	Diagnostic test	Case group, Control group

Primary outcome

Diagnostic sensitivity
Time frame: 3 years
The comparison of sensitivity between ctDNA methylation and CEA in detecting colorectal cancer

1 secondary outcome

Stage stratification
Time frame: 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Background: PubMed 33433946Siegel 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.
Background: PubMed 32877579Schilsky 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.
Background: PubMed 25326034Adler 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.
Background: PubMed 31894106Luo 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.
Background: PubMed 11957811Grotowski M. [Antigens (CEA and CA 19-9) in diagnosis and prognosis colorectal cancer]. Pol Merkur Lekarski. 2002 Jan;12(67):77-80. Polish.
Background: PubMed 25421652Kanwal 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.
Background: PubMed 30429608Shen 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.
Background: PubMed 29035356Xu 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.
Background: PubMed 33028593Xie 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.
Background: PubMed 34487783Cai 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.
Background: PubMed 34131323Liang 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.
Derived from this study: PubMed 41378988Ji H, Xu M, Hu Y, Yan B, Wu W, Zheng J, Yan J. Preoperative Identification of Lymph Node Metastasis in Colorectal Cancer Using Noninvasive Circulating Tumor DNA Methylation Signatures: Results From a Prospective Study. Dis Colon Rectum. 2026 Apr 1;69(4):586-597. doi: 10.1097/DCR.0000000000004089. Epub 2025 Dec 11.
Individual participant dataSharing planned: Undecided. Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jun Yan, M.D., Ph.D. study chair

Nanfang Hospital, Southern Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Tumor, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic sensitivity (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05558436, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.