The Implication of Plasma ctDNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas

Sponsor

Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT03737591

Collaborator

Southern Medical University, China (Other)

1,138

Enrollment

Location

140

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Adenoma	Diagnostic Test: Next-generation sequencing (NGS)

Detailed Description

Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, multicenter, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

Study Design

Study Type:

Observational

Actual Enrollment :

1138 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Implication of Plasma Circulating Tumor DNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas: a Multicenter, Cohort Study

Actual Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Healthy individuals Healthy individuals	Diagnostic Test: Next-generation sequencing (NGS) NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy
Patients with Colorectal cancer Stage I-IV colorectal cancer patients	Diagnostic Test: Next-generation sequencing (NGS) NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy
Patients with Colorectal Adenomas Patients with Colorectal Adenomas	Diagnostic Test: Next-generation sequencing (NGS) NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Arm

Intervention/Treatment

Healthy individuals

Diagnostic Test: Next-generation sequencing (NGS)

NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Patients with Colorectal cancer

Stage I-IV colorectal cancer patients

Diagnostic Test: Next-generation sequencing (NGS)

NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Patients with Colorectal Adenomas

Diagnostic Test: Next-generation sequencing (NGS)

NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Outcome Measures

Primary Outcome Measures

Sensitivity [2 years]
The sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer and adenoma
Specificity [2 years]
The specificity of plasma ctDNA methylation haplotypes in healthy individuals

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy Individuals:

Written informed consent must be obtained from healthy individuals to comply with the requirements of the study.
Healthy individuals who received colonoscopy.

Patients with Colorectal Cancer or Adenomas:

Male or female ≥ 18 years of age on the day of signing informed consent.
Patients need to receive surgical resection or endoscopic resection.
Patients must have histologically confirmed stage I-IV colorectal cancer or adenomas
Patients must have a performance status of ≤1 on the 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:

Patients received adjuvant treatment prior to the surgical resection.
Patients received blood transfusion two weeks before or during the surgical resection.
Patients with unresected advanced colorectal adenoma.
Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
Patients who are pregnant.
Patients who are alcoholic or drug abusers.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China	200032

Sponsors and Collaborators

Fudan University
Southern Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guoxiang Cai, Professor, Fudan University

ClinicalTrials.gov Identifier:

NCT03737591

Other Study ID Numbers:

FDCRCA-1

First Posted:

Nov 9, 2018

Last Update Posted:

Jan 25, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Guoxiang Cai, Professor, Fudan University

Colorectal Cancer

Adenomas

ctDNA Methylation Haplotypes

Additional relevant MeSH terms:

Colorectal Neoplasms

Adenoma

Study Results

No Results Posted as of Jan 25, 2022