RecruitingPhase 3NCT06119867

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

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

Sponsor

Russian Society of Colorectal Surgeons

Enrollment

430 participants

Start Date

Nov 14, 2023

Study Type

INTERVENTIONAL

Conditions

Colonic Neoplasms

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study compares how colon cancer surgery specimens are examined and reported by pathologists in Europe versus Japan. The goal is to identify whether differences in pathological analysis between the two regions affect treatment decisions and patient outcomes. **You may be eligible if...** - You were diagnosed with colon cancer and had surgery to remove part of your colon (colectomy) - Your tumor was confirmed to be adenocarcinoma (the most common type of colon cancer) by a pathologist - You agree to participate in the study **You may NOT be eligible if...** - You were diagnosed with rectal cancer (cancer of the lower portion of the large intestine) - You had colon cancer but did not have surgery - You declined to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREJapanese pathological investigation

Japanese pathological investigation

PROCEDUREEuropean 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(1)

Clinic of coloproctology and minimally invasive surgery

Moscow, Russia

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NCT06119867

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