Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06119867
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of postive lymph nodes'}], 'secondaryOutcomes': [{'measure': 'The role of immunohistochemical examination in the Node (N) stage determination', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of postive lymph nodes using immunohistochemical examination'}, {'measure': 'Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches', 'timeFrame': 'up to 24 months', 'description': 'LNR=Postivie lymph node/ Total retrived lymph node'}, {'measure': 'Comparison of the pT Stage between the European and Japanese pathological approaches', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of the pathological T stages'}, {'measure': 'Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of the postive proximal, distal or circular resection margin'}, {'measure': 'Comparison of the tumor budding between the European and Japanese pathological approaches', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of tumor budding'}, {'measure': 'Comparison of the tumor-infiltrating lymphocytes (TIL) count between the European and Japanese pathological approaches', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of the tumor-infiltrating lymphocytes (TIL) count'}, {'measure': 'Comparison of the extracapsular invasion between the European and Japanese pathological approaches', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of the extracapsular invasion'}, {'measure': 'Comparison of the extramural invasion (venous, lymphatic, perineural) between the European and Japanese pathological approaches', 'timeFrame': 'up to 24 months', 'description': 'indentification of the rate of the venous, lymphatic or perineural extramural invasion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Neoplasms']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with colon cancer who underwent colectomy;\n* Patients with pathological confirmed adenocarcinoma;\n* Patients agreed to participate in the study.\n\nExclusion Criteria:\n\n* Patients suffered from rectal cancer;\n* Patients diagnosed with colon cancer but did not undergo colectomy;\n* Patients refused participation.'}, 'identificationModule': {'nctId': 'NCT06119867', 'acronym': 'SPACE', 'briefTitle': 'CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)', 'organization': {'class': 'OTHER', 'fullName': 'Russian Society of Colorectal Surgeons'}, 'officialTitle': 'Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)', 'orgStudyIdInfo': {'id': '0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Japanese pathological investigation method group', 'description': '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.', 'interventionNames': ['Procedure: Japanese pathological investigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'European pathological investigation method group', 'description': 'After receiving the resected specimen, the entire process will be independently managed by the pathologist.', 'interventionNames': ['Procedure: European pathological investigation']}], 'interventions': [{'name': 'Japanese pathological investigation', 'type': 'PROCEDURE', 'description': 'Japanese pathological investigation', 'armGroupLabels': ['Japanese pathological investigation method group']}, {'name': 'European pathological investigation', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['European pathological investigation method group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mingze He', 'role': 'CONTACT', 'email': 'hemingze97@gmail.com', 'phone': '+79801881266'}, {'name': 'Vladimir Balaban', 'role': 'CONTACT', 'email': 'balaban@kkmx.ru', 'phone': '+79889478358'}], 'facility': 'Clinic of coloproctology and minimally invasive surgery', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Mingze He', 'role': 'CONTACT', 'email': 'hemingze97@gmail.com', 'phone': '+79801881266'}], 'overallOfficials': [{'name': 'Vladimir Balaban', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sechenov University'}, {'name': 'Petr Tsarkov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sechenov University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russian Society of Colorectal Surgeons', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vladimir Balaban', 'investigatorAffiliation': 'Russian Society of Colorectal Surgeons'}}}}