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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737591
• Other study ID #: FDCRCA-1
• Status: Completed
• Start date: May 1, 2010
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1138
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Next-generation sequencing (NGS)
NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	The sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer and adenoma	2 years
Primary	Specificity	The specificity of plasma ctDNA methylation haplotypes in healthy individuals	2 years