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

NCT06119867 | Recruiting Phase 3

• 1 other identifier: 0004
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The role of immunohistochemical examination in the Node (N) stage determination

  up to 24 months

• Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches

  up to 24 months

• Comparison of the pT Stage between the European and Japanese pathological approaches

  up to 24 months

• Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches

  up to 24 months

• Comparison of the tumor budding between the European and Japanese pathological approaches

  up to 24 months

Study Arms (2)

Japanese pathological investigation method group

EXPERIMENTAL

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

European pathological investigation method group

ACTIVE COMPARATOR

After receiving the resected specimen, the entire process will be independently managed by the pathologist.

Procedure: European pathological investigation

Interventions

Japanese pathological investigation PROCEDURE

Japanese pathological investigation

Japanese pathological investigation method group

European pathological investigation PROCEDURE

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.

European pathological investigation method group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with colon cancer who underwent colectomy;
• Patients with pathological confirmed adenocarcinoma;
• Patients agreed to participate in the study.

You may not qualify if:

• Patients suffered from rectal cancer;
• Patients diagnosed with colon cancer but did not undergo colectomy;
• Patients refused participation.

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead

Study Sites (1)

Clinic of coloproctology and minimally invasive surgery

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Vladimir Balaban

  Sechenov University

  PRINCIPAL INVESTIGATOR

• Petr Tsarkov

  Sechenov University

  STUDY DIRECTOR

Central Study Contacts

Mingze He

CONTACT

+79801881266; hemingze97@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 7, 2023
• Study Start: November 14, 2023
• Primary Completion: October 12, 2025
• Study Completion: December 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)