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Trial Title:
CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)
NCT ID:
NCT06119867
Condition:
Colonic Neoplasms
Conditions: Official terms:
Colonic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Japanese pathological investigation
Description:
Japanese pathological investigation
Arm group label:
Japanese pathological investigation method group
Intervention type:
Procedure
Intervention name:
European pathological investigation
Description:
The European pathology evaluation method involves the analysis of fresh and intact
specimens. Pathologists carefully inspect the entire specimen's appearance and assess the
surgical resection plane and capture complete photographs for documentation purposes
before further sectioning the specimen. During specimen processing, the CRM is initially
marked with ink or other markers. After fixation, macroscopic data are recorded, and the
entire length of the intestine is cut into cross-sections at intervals of 3-4
millimeters. These sections are then undergoing subsequent systematic pathological
examination. However, the surgeon will be involved in the Japanese pathological
investigation method. Intraoperative markings will be made 10 cm bilaterally from the
primary tumor area. The resected colon will be incised at 1 cm intervals, after which the
pericolic lymph nodes will be harvested. Each single retrieved lymph node will be packed
up independently and will be examined by the pathologist.
Arm group label:
European pathological investigation method group
Summary:
In general, the European pathological examination method primarily relies on pathologists
and does not require the involvement of surgeons. The Japanese pathological evaluation
approach, on the other hand, involves the intervention of surgeons, particularly in the
extraction of lymph nodes from fresh specimens and the assessment of specimen quality.
Given that the Japanese pathological assessment method lacks systematic evaluation and
there is currently no literature clearly demonstrating its diagnostic accuracy, the main
objective of this study is to verify whether the diagnostic accuracy of the Japanese
pathological investigation method is inferior to that of the European pathological
evaluation method.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients diagnosed with colon cancer who underwent colectomy;
- Patients with pathological confirmed adenocarcinoma;
- Patients agreed to participate in the study.
Exclusion Criteria:
- Patients suffered from rectal cancer;
- Patients diagnosed with colon cancer but did not undergo colectomy;
- Patients refused participation.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinic of coloproctology and minimally invasive surgery
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Mingze He
Phone:
+79801881266
Email:
hemingze97@gmail.com
Contact backup:
Last name:
Vladimir Balaban
Phone:
+79889478358
Email:
balaban@kkmx.ru
Start date:
November 14, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Russian Society of Colorectal Surgeons
Agency class:
Other
Source:
Russian Society of Colorectal Surgeons
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06119867
