A Phase 3 interventional study of Japanese pathological investigation and European pathological investigation in Colonic Neoplasms, sponsored by Russian Society of Colorectal Surgeons. Recruiting at 1 site in Russia. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Russian Society of Colorectal Surgeons · Phase 3, Interventional, and Diagnostic
Among 11 studies in Colonic Neoplasms with a site in Russia — 4 open to participants now, 7 under way, 3 of them phase 3. Colonic Neoplasms · Russia.
Among the 11 studies in Colonic Neoplasms with a site in Russia, this one is one of 2 that started in 2023, is one of 3 in phase 3, and was the 7th registered.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 430 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →4 of the 11 studies in Colonic Neoplasms with a site in Russia are open now, in 11 countries. Each count lists the studies.
Of the 326 Colonic Neoplasms studies recruiting now, 203 (62%) set no upper age limit and 71 (22%) stop at 75 or younger; 19 take children under 18; 34 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2023.
Median enrollment 669 across the 6 interventional studies, 700 across the 5 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
3 of 11 have an industry lead sponsor. The 9 most frequent:
Russian Society of Colorectal Surgeons is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Russian Society of Colorectal Surgeons has 2 studies filed under Colonic Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Colonic Neoplasms with a site in Russia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06119867Phase 3Russian Society of Colorectal SurgeonsCompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE) | 2027-04-12 |
| NCT06043947N.N. Petrov National Medical Research Center of OncologySurvival Monitoring in Russian Cancer Registries | 2026-12-31 |
| NCT07448662Blokhin's Russian Cancer Research CenterLocal Treatment Strategies for Brain Metastases of Colorectal Cancer | 2027-10-01 |
Among the 11 studies in Colonic Neoplasms with a site in Russia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
After receiving the resected specimen, the entire process will be independently managed by the pathologist.
Procedure: European pathological investigation
Japanese 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.
Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.
indentification of the rate of postive lymph nodes
Time frame: up to 24 months
The role of immunohistochemical examination in the Node (N) stage determination
indentification of the rate of postive lymph nodes using immunohistochemical examination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 24 months
Comparison of the tumor budding between the European and Japanese pathological approaches
indentification of the rate of tumor budding
Time frame: 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
Time frame: up to 24 months
Comparison of the extracapsular invasion between the European and Japanese pathological approaches
indentification of the rate of the extracapsular invasion
Time frame: 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
Time frame: up to 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Apr 2027, 40 months after the start.
Of 55 non-industry phase 3 interventional studies under Colonic Neoplasms, half reached primary completion within 87 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 123. This study's planned 40 months is below that.
Counting every sponsor, half of 72 studies reached it within 55 months; a quarter within 37 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
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Russian Society of Colorectal Surgeons