Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis

Colorectal Cancer Clinical Trial

Official title:

Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis: a Prospective, Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868215
• Other study ID #: FDLNM-CGX
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2019
• Source: Fudan University
• Contact: Guoxiang Cai, M.D. Ph.D.
• Phone: +86 13611831623
• Email: gxcai[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.

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 2181 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, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with endoscopically removed malignant polyps.

• Male or female = 18 years of age on the day of signing informed consent.

• Patients who received surgical resection following removal of malignant polyps by colonoscopy.

• 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

• Colorectal Cancer
• Colorectal Neoplasms
• Lymph Node Metastases
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

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 local residual or lymph node metastasis	2 years