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

Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)

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.

Study Overview

• Status: Recruiting
• Conditions: Colonic Neoplasms
• Intervention / Treatment: Procedure: Japanese pathological investigation; Procedure: European pathological investigation

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mingze He; Phone Number: +79801881266; Email: hemingze97@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Clinic of coloproctology and minimally invasive surgery
    • Contact: Mingze He; Phone Number: +79801881266; Email: hemingze97@gmail.com
    • Contact: Vladimir Balaban; Phone Number: +79889478358; Email: balaban@kkmx.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Japanese pathological investigation method group; 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.	Procedure: Japanese pathological investigation; Japanese pathological investigation
Active Comparator: European pathological investigation method group; After receiving the resected specimen, the entire process will be independently managed by the pathologist.	Procedure: European pathological investigation; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Investigators: Principal Investigator: Vladimir Balaban, Sechenov University; Study Director: Petr Tsarkov, Sechenov University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): October 12, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No