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

NCT03868215 | Unknown DMC

• 1 other identifier: FDLNM-CGX
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Lymph Node Metastases

Keywords

Colorectal Cancer; Lymph Node Metastases; Local Residual

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  The sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis

  2 years

Study Arms (1)

Patients with endoscopically removed malignant polyps

Patients with endoscopically removed malignant polyps

Diagnostic Test: Next-generation sequencing (NGS)

Interventions

Next-generation sequencing (NGS) DIAGNOSTIC_TEST

NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy and before surgical resection.

Patients with endoscopically removed malignant polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with endoscopically removed malignant polyps must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guoxiang Cai, M.D. Ph.D.

CONTACT

+86 13611831623; gxcai@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: March 11, 2019
• Study Start: May 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2020
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

CN (1)