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Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status

Primary Purpose

Advanced Gastric Cancer, Neoadjuvant Chemotherapy, Palliative Chemotherapy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Confocal group
Control group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Advanced Gastric Cancer focused on measuring pCLE, confocal, Advanced gastric cancer, chemotherapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A. Older than 20 years old and younger than 80 years old B. Patients who completed neoadjuvant chemotherapy with AGC C. Patients who underwent palliative chemotherapy with AGC

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

Sites / Locations

  • Yonsei university of medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Target biopsy under pCLE

Random biopsy at cancer lesion under WLE

Arm Description

(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)

WLE (GIF-HQ290, Olympus, Japan) group

Outcomes

Primary Outcome Measures

The percentage of remnant cancer cells in biopsy samples
The percentage of remnant cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy

Secondary Outcome Measures

pCLE findings of residual cancer cells after chemotherapy
The specific findins of remnant cancer cells under probe-based confocal laser endomicroscopy (ex. Destruction of gland structure, increased numbers of blood vessel, dark cells…)

Full Information

First Posted
February 22, 2018
Last Updated
January 10, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03449966
Brief Title
Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status
Official Title
Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
* single center, prospective study First, evaluate the lesion under the white light endoscopy (WLE) → IV fluorescein sodium 0.1mL/kg → evaluate the lesion under probe-based confocal laser microendoscopy → target biopsy under the pCLE → random biopsy under WLE
Detailed Description
The purpose of this study is to conduct a study on genetic pathology, obtaining of 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 of patients after chemotherapy is usually 30% or less. Because cancer cells are often replaced with regenerative cells after chemotherapy, even though there are still remnant cancer cells in the stomach. 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 no previous study about precious biopsy method for patients after chemotherapy. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for remnant gastric cancer after chemotherapy will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer, Neoadjuvant Chemotherapy, Palliative Chemotherapy
Keywords
pCLE, confocal, Advanced gastric cancer, chemotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All procedures were performed with both WLE and pCLE. One patient underwent both WLE and pCLE. Target biopsy under pCLE and random biopsy at cancer lesion under WLE will be done for one patient. The proportion of remnant cancer cells in biopsy samples will be compared.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Target biopsy under pCLE
Arm Type
Experimental
Arm Description
(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)
Arm Title
Random biopsy at cancer lesion under WLE
Arm Type
Active Comparator
Arm Description
WLE (GIF-HQ290, Olympus, Japan) group
Intervention Type
Device
Intervention Name(s)
Confocal group
Other Intervention Name(s)
pCLE group
Intervention Description
Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.
Intervention Type
Device
Intervention Name(s)
Control group
Intervention Description
Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.
Primary Outcome Measure Information:
Title
The percentage of remnant cancer cells in biopsy samples
Description
The percentage of remnant cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
Time Frame
within the first day after pCLE
Secondary Outcome Measure Information:
Title
pCLE findings of residual cancer cells after chemotherapy
Description
The specific findins of remnant cancer cells under probe-based confocal laser endomicroscopy (ex. Destruction of gland structure, increased numbers of blood vessel, dark cells…)
Time Frame
within the first day after pCLE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A. Older than 20 years old and younger than 80 years old B. Patients who completed neoadjuvant chemotherapy with AGC C. Patients who underwent palliative chemotherapy with AGC 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Kil Lee, MD
Phone
82-2-2228-1996
Email
sklee@yuhs.ac
Facility Information:
Facility Name
Yonsei university of medical center
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Kil Lee, MD
Phone
82-2-2228-1996
Email
sklee@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status

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