Colonic NeoplasmsPhase 3SPACENCT06119867
CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)
A Phase 3 study testing Japanese pathological investigation and European pathological investigation in people with Colonic Neoplasms, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Japanese pathological investigation and European pathological investigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteRussia
- Study dates
- 14 Nov 2023to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with colon cancer who underwent colectomy;
- Patients with pathological confirmed adenocarcinoma;
- Patients agreed to participate in the study.
Who cannot join
- Patients suffered from rectal cancer;
- Patients diagnosed with colon cancer but did not undergo colectomy;
- Patients refused participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Clinic of coloproctology and minimally invasive surgery
Moscow
Mingze He, +79801881266, hemingze97@gmail.com
Vladimir Balaban, +79889478358, balaban@kkmx.ru
About this study
Official title: 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.
- Conditions
- Colonic Neoplasms
- Being tested
- Japanese pathological investigation, European pathological investigation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese pathological investigationProcedure or surgery
Japanese pathological investigation
European pathological investigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: European pathological investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.
indentification of the rate of postive lymph nodes
Measured: up to 24 months
Secondary outcomes (8)
The role of immunohistochemical examination in the Node (N) stage determination
indentification of the rate of postive lymph nodes using immunohistochemical examination
Measured: 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
Measured: 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
Measured: 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
Measured: up to 24 months
Comparison of the tumor budding between the European and Japanese pathological approaches
indentification of the rate of tumor budding
Measured: 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
Measured: up to 24 months
Comparison of the extracapsular invasion between the European and Japanese pathological approaches
indentification of the rate of the extracapsular invasion
Measured: 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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start14 Nov 2023
- Primary completion12 Apr 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Balaban, Russian Society of Colorectal Surgeons
- Investigators
- Vladimir Balaban, Principal investigator, Sechenov UniversityPetr Tsarkov, Study director, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119867
- Sponsor's protocol ID
- 0004
- Acronym
- SPACE
- Status last verified
- Aug 2026
- First submitted
- 12 Oct 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)
- ClinicalTrials.gov ID
- NCT06119867
- Acronym / sponsor ID
- SPACE / 0004
- Conditions
- Colonic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 12 Apr 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Japanese pathological investigation method group | Experimental | Procedure: Japanese pathological investigationThe 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. |
| European pathological investigation method group | Active comparator | Procedure: European pathological investigationAfter receiving the resected specimen, the entire process will be independently managed by the pathologist. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with colon cancer who underwent colectomy;
- Patients with pathological confirmed adenocarcinoma;
- Patients agreed to participate in the study.
Key exclusion criteria (3 listed)
- Patients suffered from rectal cancer;
- Patients diagnosed with colon cancer but did not undergo colectomy;
- Patients refused participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Japanese pathological investigationJapanese pathological investigation | Procedure or surgery | Japanese pathological investigation method group |
| European pathological investigationThe 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. | Procedure or surgery | European pathological investigation method group |
Primary outcome
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
8 secondary outcomes
The role of immunohistochemical examination in the Node (N) stage determination
Time frame: up to 24 months
Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches
Time frame: up to 24 months
Comparison of the pT Stage between the European and Japanese pathological approaches
Time frame: up to 24 months
Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches
Time frame: up to 24 months
Comparison of the tumor budding between the European and Japanese pathological approaches
Time frame: up to 24 months
Comparison of the tumor-infiltrating lymphocytes (TIL) count between the European and Japanese pathological approaches
Time frame: up to 24 months
Comparison of the extracapsular invasion between the European and Japanese pathological approaches
Time frame: up to 24 months
Comparison of the extramural invasion (venous, lymphatic, perineural) between the European and Japanese pathological approaches
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vladimir Balaban principal investigator
Sechenov University
Petr Tsarkov study director
Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Japanese pathological investigation and European pathological investigation in people with Colonic Neoplasms, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingze He (+79801881266, hemingze97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods. (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.