- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03449966
Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sang Kil Lee, MD
- Phone Number: 82-2-2228-1996
- Email: sklee@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Recruiting
- Yonsei university of medical center
-
Contact:
- Sang Kil Lee, MD
- Phone Number: 82-2-2228-1996
- Email: sklee@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Target biopsy under pCLE
(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)
|
Under pCLE, target biopsy at cancer lesion will be done.
5 pieces of forcep biopsy will be obtained.
Other Names:
|
Active Comparator: Random biopsy at cancer lesion under WLE
WLE (GIF-HQ290, Olympus, Japan) group
|
Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of remnant cancer cells in biopsy samples
Time Frame: within the first day after pCLE
|
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
|
within the first day after pCLE
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pCLE findings of residual cancer cells after chemotherapy
Time Frame: within the first day after pCLE
|
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…)
|
within the first day after pCLE
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2017-0770
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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