Status:
UNKNOWN
Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis
Lead Sponsor:
Fudan University
Conditions:
Colorectal Cancer
Lymph Node Metastases
Eligibility:
All Genders
18+ years
Brief 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.
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 plas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03868215
Start Date
May 1 2018
End Date
August 31 2020
Last Update
March 11 2019
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032