Colorectal Cancer Clinical Trial
Official title:
Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis: a Prospective, Clinical Study
NCT number | NCT03868215 |
Other study ID # | FDLNM-CGX |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | August 31, 2020 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
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 |
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