Clinical trial NCT06119867: CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)
Official title: Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colonic Neoplasms
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.
timeFrame: up to 24 months
Secondary outcomes:
measure: The role of immunohistochemical examination in the Node (N) stage determination
timeFrame: up to 24 months
measure: Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches
timeFrame: up to 24 months
measure: Comparison of the pT Stage between the European and Japanese pathological approaches
timeFrame: up to 24 months
measure: Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches
timeFrame: up to 24 months
measure: Comparison of the tumor budding between the European and Japanese pathological approaches
timeFrame: up to 24 months
measure: Comparison of the tumor-infiltrating lymphocytes (TIL) count between the European and Japanese pathological approaches
timeFrame: up to 24 months
measure: Comparison of the extracapsular invasion between the European and Japanese pathological approaches
timeFrame: up to 24 months
measure: Comparison of the extramural invasion (venous, lymphatic, perineural) between the European and Japanese pathological approaches
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of coloproctology and minimally invasive surgery
Study officials:
affiliation: Sechenov University
name: Vladimir Balaban
role: PRINCIPAL_INVESTIGATOR
affiliation: Sechenov University
name: Petr Tsarkov
role: STUDY_DIRECTOR
References: