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

NCT ID: NCT03737591

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-01
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Colorectal Cancer; Adenoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy individuals

Healthy individuals

Next-generation sequencing (NGS)

Intervention Type: DIAGNOSTIC_TEST

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

Patients with Colorectal cancer

Stage I-IV colorectal cancer patients

Next-generation sequencing (NGS)

Intervention Type: DIAGNOSTIC_TEST

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

Patients with Colorectal Adenomas

Patients with Colorectal Adenomas

Next-generation sequencing (NGS)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Next-generation sequencing (NGS)

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Guoxiang Cai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

References

Mo S, Dai W, Wang H, Lan X, Ma C, Su Z, Xiang W, Han L, Luo W, Zhang L, Wang R, Zhang Y, Zhang W, Yang L, Lu R, Guo L, Zheng Y, Huang M, Xu Y, Liang L, Cai S, Cai G. Early detection and prognosis prediction for colorectal cancer by circulating tumour DNA methylation haplotypes: A multicentre cohort study. EClinicalMedicine. 2022 Nov 3;55:101717. doi: 10.1016/j.eclinm.2022.101717. eCollection 2023 Jan.

Reference Type: DERIVED

PMID: 36386039 (View on PubMed)

Other Identifiers

FDCRCA-1

Identifier Type: -

Identifier Source: org_study_id