NCT05208372

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

January 13, 2022

Last Update Submit

January 13, 2022

Conditions

Stomach NeoplasmsMetastasis

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (3)

  • Quantity of CTCs

    To count the circulating tumor cells in ascites and blood.

    1 day

  • Classification of CTCs

    To classify the circulating tumor cells in ascites and blood.

    1 day

  • Expression of ctDNA

    To assess the expression of circulating tumor DNA in ascites and blood, including YAP1, LAMC1 and DDIT4.

    1 day

Study Arms (2)

Laparotomy group

Patients who undergo radical laparotomy for gastric cancer.

Diagnostic Test: CTC testDiagnostic Test: ctDNA test

Laparoscopy group

Patients who undergo laparoscope-assisted radical gastrectomy for gastric cancer.

Diagnostic Test: CTC testDiagnostic Test: ctDNA test

Interventions

CTC testDIAGNOSTIC_TEST

Circulating tumor cells test of ascites and blood for patients with gastric cancer.

Laparoscopy groupLaparotomy group
ctDNA testDIAGNOSTIC_TEST

Circulating tumor DNA test of ascites and blood for patients with gastric cancer.

Laparoscopy groupLaparotomy group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121012, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm MetastasisDisease

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kai Li, MD

    First Hospital of China Medical University

    STUDY DIRECTOR

Central Study Contacts

Kai Li, MD

CONTACT

8613998245233cmu1h_likai@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of surgical Oncology

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 26, 2022

Study Start

January 1, 2022

Primary Completion

February 1, 2023

Study Completion

January 31, 2024

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

CN(2)