MedDataX Logo

Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer

NCT ID: NCT02799420

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-20

Study Completion Date

2017-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Undifferentiated Gastric Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

confocal laser endomicroscopy undifferentiated gastric cancer target biopsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pCLE group

The intervention group

Group Type EXPERIMENTAL

GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France

Intervention Type DEVICE

The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.

WLE group

The control group

Group Type ACTIVE_COMPARATOR

white light endoscopy (WLE)

Intervention Type DEVICE

The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France

The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.

Intervention Type DEVICE

white light endoscopy (WLE)

The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery

Exclusion Criteria

A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yonsei university of medical center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2016-0257

Identifier Type: -

Identifier Source: org_study_id