NCT06119867 CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)
| NCT ID | NCT06119867 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Russian Society of Colorectal Surgeons |
| Condition | Colonic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 430 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2027-04-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 430 participants in total. It began in 2023-11-14 with a primary completion date of 2027-04-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Vladimir Balaban
PRINCIPAL INVESTIGATOR
Sechenov University
Frequently Asked Questions
Who can join the NCT06119867 clinical trial?
This trial is open to participants of all sexes, studying Colonic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06119867 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 430 participants.
Is NCT06119867 currently recruiting?
Yes, NCT06119867 is actively recruiting participants. Contact the research team at hemingze97@gmail.com for enrollment information.
Where is the NCT06119867 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06119867 clinical trial?
NCT06119867 is sponsored by Russian Society of Colorectal Surgeons. The principal investigator is Vladimir Balaban at Sechenov University. The trial plans to enroll 430 participants.