Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer (CTC_ctDNA)

January 13, 2022 updated by: Kai Li, First Hospital of China Medical University

Application of the Detection of Circulating Tumor Cell and Circulating Tumor DNA in the Diagnosis of Metastasis in Gastric Cancer

To investigate the value of CTCs and ctDNA in the diagnosis of metastasis in ascites/peritoneal flushing fluid and blood; To investigate the influence of laparoscopic CO2 pneumoperitoneum establishment on peritoneal and hematogenous metastasis of advanced gastric cancer; To explore the influence of the number and type of CTCs and ctDNA on metastasis and prognosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Jinzhou, Liaoning, China, 121012
        • Recruiting
        • First Hospital of Jinzhou Medical University
        • Contact:
          • Yubin Wang
      • Shenyang, Liaoning, China, 110000
        • Active, not recruiting
        • The First Affiliated Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Borrmann III and Borrmann IV patients will be selected from Department of Oncology in hospitals. All patients will undergo either laparotomy or laparoscopic surgery.

Description

Inclusion Criteria:

  1. Patients who sign informed consent.
  2. Gastric cancer is determined by more than 2 pathologists.
  3. Patients with Borrmann III/IV gastric cancer.

Exclusion Criteria:

  1. Patients who complicate with other malignant tumors.
  2. Patients who complicate with other serious heart and lung diseases.
  3. Patients who receive preoperative neoadjuvant chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laparotomy group
Patients who undergo radical laparotomy for gastric cancer.
Diagnostic test: CTC test
Circulating tumor cells test of ascites and blood for patients with gastric cancer.
Diagnostic test: ctDNA test
Circulating tumor DNA test of ascites and blood for patients with gastric cancer.
Laparoscopy group
Patients who undergo laparoscope-assisted radical gastrectomy for gastric cancer.
Diagnostic test: CTC test
Circulating tumor cells test of ascites and blood for patients with gastric cancer.
Diagnostic test: ctDNA test
Circulating tumor DNA test of ascites and blood for patients with gastric cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantity of CTCs
Time Frame: 1 day
To count the circulating tumor cells in ascites and blood.
1 day
Classification of CTCs
Time Frame: 1 day
To classify the circulating tumor cells in ascites and blood.
1 day
Expression of ctDNA
Time Frame: 1 day
To assess the expression of circulating tumor DNA in ascites and blood, including YAP1, LAMC1 and DDIT4.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Investigators

  • Study Director: Kai Li, MD, First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstHCMU_CTC_ctDNA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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