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NCT Number: NCT06119867

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Japanese pathological investigation

Procedure

Japanese pathological investigation

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.

Primary outcomes

  1. Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.

    Time frame: up to 24 months

    indentification of the rate of postive lymph nodes

Secondary outcomes

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

    Time frame: up to 24 months

    indentification of the rate of postive lymph nodes using immunohistochemical examination

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

    Time frame: up to 24 months

    LNR=Postivie lymph node/ Total retrived lymph node

  3. Comparison of the pT Stage between the European and Japanese pathological approaches

    Time frame: up to 24 months

    indentification of the rate of the pathological T stages

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

    Time frame: up to 24 months

    indentification of the rate of the postive proximal, distal or circular resection margin

  5. Comparison of the tumor budding between the European and Japanese pathological approaches

    Time frame: up to 24 months

    indentification of the rate of tumor budding

  6. Comparison of the tumor-infiltrating lymphocytes (TIL) count between the European and Japanese pathological approaches

    Time frame: up to 24 months

    indentification of the rate of the tumor-infiltrating lymphocytes (TIL) count

  7. Comparison of the extracapsular invasion between the European and Japanese pathological approaches

    Time frame: up to 24 months

    indentification of the rate of the extracapsular invasion

  8. Comparison of the extramural invasion (venous, lymphatic, perineural) between the European and Japanese pathological approaches

    Time frame: up to 24 months

    indentification of the rate of the venous, lymphatic or perineural extramural invasion

Study contacts

Contact information is provided by the study sponsor or research team.

Mingze He

CONTACT

[email protected]

+79801881266

Sponsors and collaborators

Lead sponsor

Russian Society of Colorectal Surgeons

Other

Registry information

Acronym: SPACE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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