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

Colonic Neoplasms Clinical Trial

— SPACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119867
• Other study ID #: 0004
• Status: Recruiting
• Phase: Phase 3
• Start date: November 14, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Russian Society of Colorectal Surgeons
• Contact: Mingze He
• Phone: +79801881266
• Email: hemingze97[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: December 1, 2025
• Est. primary completion date: October 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Procedure:
• Japanese pathological investigation
Japanese pathological investigation
• 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.

Locations

Country	Name	City	State
Russian Federation	Clinic of coloproctology and minimally invasive surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Comparison of the tumor budding between the European and Japanese pathological approaches	indentification of the rate of tumor budding	up to 24 months
Secondary	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
Secondary	Comparison of the extracapsular invasion between the European and Japanese pathological approaches	indentification of the rate of the extracapsular invasion	up to 24 months
Secondary	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