CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)

Phase 3

Recruiting

• Conditions: Colonic Neoplasms
• Interventions: Procedure: Japanese pathological investigation; Procedure: European pathological investigation

• Registration Number: NCT06119867
• Lead Sponsor: Russian Society of Colorectal Surgeons

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Study Start: 2023-11-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-10-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 430

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Japanese pathological investigation method group	Japanese pathological investigation	The surgeon will be involved into the Japanese pathological investigation method. The surgeon will perform the intraoperative markings and the postoperative lymph node harvest, after which the specimen will be assessed by the pathologist.
European pathological investigation method group	European pathological investigation	After receiving the resected specimen, the entire process will be independently managed by the pathologist.

Primary Outcome Measures

Name	Time	Method
Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.	up to 24 months	indentification of the rate of postive lymph nodes

Secondary Outcome Measures

Name	Time	Method
The role of immunohistochemical examination in the Node (N) stage determination	up to 24 months	indentification of the rate of postive lymph nodes using immunohistochemical examination
Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches	up to 24 months	indentification of the rate of the postive proximal, distal or circular resection margin
Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches	up to 24 months	LNR=Postivie lymph node/ Total retrived lymph node
Comparison of the tumor budding between the European and Japanese pathological approaches	up to 24 months	indentification of the rate of tumor budding
Comparison of the tumor-infiltrating lymphocytes (TIL) count between the European and Japanese pathological approaches	up to 24 months	indentification of the rate of the tumor-infiltrating lymphocytes (TIL) count
Comparison of the pT Stage between the European and Japanese pathological approaches	up to 24 months	indentification of the rate of the pathological T stages
Comparison of the extracapsular invasion between the European and Japanese pathological approaches	up to 24 months	indentification of the rate of the extracapsular invasion
Comparison of the extramural invasion (venous, lymphatic, perineural) between the European and Japanese pathological approaches	up to 24 months	indentification of the rate of the venous, lymphatic or perineural extramural invasion

Trial Locations

Locations (1)

Clinic of coloproctology and minimally invasive surgery; 🇷🇺 Moscow, Russian Federation